(108 days)
No
The summary describes a cold plasma-based device for preventing lens fogging and does not mention any AI or ML components or functionalities.
No.
The device prevents fogging of an endoscopic scope lens and does not interact directly with the patient's body or have a therapeutic effect on a disease or condition.
No
The device is intended to prevent fogging of scope lenses during endoscopic procedures, not to diagnose a condition or disease.
No
The device description explicitly states it is a "cold plasma-based device" and performs "cold plasma treatment," indicating it is a hardware device that physically interacts with the scope lens.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Plasma Shield Function: The Plasma Shield's intended use is to prevent fogging of an endoscopic scope lens during a procedure. It works by treating the surface of the scope lens with cold plasma.
- No Interaction with Patient Samples: The description explicitly states that the device "does not interact directly with the patient's body." It is used on the surgical instrument itself, not on a biological sample from the patient.
Therefore, the Plasma Shield falls outside the scope of an in vitro diagnostic device. It is a device used to improve the visualization during a surgical procedure.
N/A
Intended Use / Indications for Use
The Plasma Shield is to be used prior to and during endoscopic procedures to prevent fogging of the scope lens. The Plasma Shield is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens
Product codes (comma separated list FDA assigned to the subject device)
GCJ, OCT
Device Description
The Plasma Shield is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. The Plasma Shield device is designed for reducing laparoscopic lens fogging by performing cold plasma treatment of a laparoscope lens. The Plasma Shield device is a cold plasma-based device to be used in an operating room, prior to and during laparoscopic procedures. The cold plasma creates a super hydrophilic scope lens surface after treatment (aka activation). The device does not interact directly with the patient's body.
The Plasma Shield consists of these components and accessories:
- The main system is a Reusable Part (RP) that generates the cold plasma required to treat the scope for defogging.
- A Disposable Part (DP) a single-use, sterilized component interfacing with the scope itself and used for each procedure (can be used multiple times within the same procedure for the same patient). The DP assembly includes a folded surgical drape and packaged in a pouch.
A single-use, sterile anti-fog solution and foam is supplied together with the Disposable Part.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals and/or surgery centres on or by the order of a physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance testing was conducted on the proposed subject device to determine the performance and efficacy of the device. In addition, Performance testing – animal was conducted on the proposed subject device to compare the anti-fogging effect of Plasma Shield vs. Clearify™ devices during laparoscopy in swine. The study demonstrated the anti-fogging effect for both the proposed subject device and the predicate device.
Validation of product performance in compliance with the following product specification requirements was conducted on the proposed subject device:
- PRSJ.02: Scope's lens surface characteristics immediately post treatment (aka activation): Plasma-induced surface activation should create a hydrophilic scope lens surface to reduce scope lens fogging as effectively as the predicate device, thereby demonstrating substantial equivalence.
- PRS 4.3: The Plasma Shield interfaces with laparoscopes of 5mm and 10mm diameter, with 0-45 angles.
- PRS H.07: The system shall perform lens activation for scopes of 0, 30, and 45 angles, and different materials
The Plasma activated lenses of all tested scope are Super Hydrophilic and comparison to untreated lenses show highly improved contact angles. Product performance comply with the specification requirements. Therefore, plasma surface activation induced hydrophilicity reduces scope lens fogging, conferring substantial equivalence with the predicate device working mechanism. Comparison with the predicate and reference devices regarding functional characteristics shows that the subject device is intended for equivalent procedures as compared to the predicate and reference devices and makes use of similar functionality.
Comparison of Proposed Subject Device Plasma Shield Vs. Clearify Predicate Device, Anti-Fogging Devices was conducted during Laparoscopy in Swine to compare the antifogging hydrophilicity effect of Plasma Shield vs. Clearify™ devices during laparoscopy in swine in order to demonstrate substantial equivalence.
Overall, both Plasma Shield and Clearify scope pretreatment received a higher score compared to none treated scope following video evaluation in all experimental conditions tested. These suggest that pretreatment of the scope with Plasma Shield or Clearify was more effective in preventing fog formation on the scope during laparoscopy compared to no treatment in these experimental settings. It can be concluded that Plasma Shield scope pretreatment is comparable to Clearify in its effectiveness to prevent fogging on the scope during laparoscopy and both are better in grading than no treatment, therefore demonstrating substantial equivalence between the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
September 12, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Plasmatica LTD % Vaibhav Rajal Official Correspondent for Plasmatica LTD MDI Consultants Inc 55 Northern Blvd Great Neck, New York 11021
Re: K221533
Trade/Device Name: Plasma Shield Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, OCT Dated: May 2, 2022 Received: May 27, 2022
Dear Vaibhav Rajal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221533
Device Name Plasma Shield
Indications for Use (Describe)
The Plasma Shield is to be used prior to and during endoscopic procedures to prevent fogging of the scope lens
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Sponsor: PLASMATICA Subject Device: Plasma Shield, Model: .1.0 Document Name: FDA 510(k) Company Cover Letter
510(k) SUMMARY
The assigned 510(k) number is K221533
1. Submitter's Identification:
Plasmatica LTD. HaTa'asiya ST 25 Ra'anana, Israel. 4365413.
| Contact Person: | Mr. Adam Sagiv
Chief Executive Officer and Founder |
|-----------------|-------------------------------------------------------|
| Telephone: | +972-52-2232562 |
| Email: | Adam@plasmatica.com |
Date Summary Prepared: September 8, 2022
2. Name of the Device:
| Trade Name: | Plasma Shield |
|---|---|
| Regulation Number: | 21 CFR 876.1500 |
| Regulatory Class: | Class II |
| Product Code: | OCT, GCJ |
3. Information for the 510(k) Cleared Device (Predicate Device):
| FDA Product Code | Common Name | Regulation Number |
|---|---|---|
| OCT | Anti-Fog Solution And Accessories, Endoscopy | 876.1500 |
| GCJ | Laparoscope, General & Plastic Surgery | 876.1500 |
4. Device Description:
The Plasma Shield is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. The Plasma Shield device is designed for reducing laparoscopic lens fogging by performing cold plasma treatment of a laparoscope lens. The Plasma Shield device is a cold plasma-based device to be used in an operating room, prior to and during laparoscopic procedures. The cold plasma creates a super hydrophilic scope lens surface after treatment (aka activation). The device does not interact directly with the patient's body.
The Plasma Shield consists of these components and accessories:
- The main system is a Reusable Part (RP) that generates the cold plasma . required to treat the scope for defogging.
- A Disposable Part (DP) a single-use, sterilized component interfacing with the ● scope itself and used for each procedure (can be used multiple times within the
4
same procedure for the same patient). The DP assembly includes a folded surgical drape and packaged in a pouch.
A single-use, sterile anti-fog solution and foam is supplied together with the Disposable Part.
5. Indications for Use:
The Plasma Shield is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens
6. Comparison to the 510(k) Cleared Devices (Predicate Devices):
Table of Comparison to Legally Marketed Device and Discussion of Similarities and Differences:
The proposed subject device is being compared to the predicate devices identified under Section 1(i): Identification of Legally Marketed Device Which We Claim Substantial Equivalence;
| Parameters | Subject Device | Primary Device | Predicate | Reference Device | Predicate | Similarities or Differences |
|---|---|---|---|---|---|---|
| Device Name | Plasma Shield | Scope System/See Sharp | Antifogging | DHELP/Clearify | ||
| Manufacturer | Plasmatica Ltd. | Xodus Medical, Inc. | New Wave/Medtronic | |||
| Regulatory Pathway | 510(k) | 510(k) | 510(k) | Same | ||
| 510(k)/De Novo number | TBD | K182080 | K062779 | |||
| Classification | II | II | II | Same | ||
| Product Code | GCJ, OCT | GCJ, OCT | GCJ, OCT | Same | ||
| Regulation Number | 876.1500 | 876.1500 | 876.1500 | Same | ||
| Regulation Name | Endoscope and accessories | Endoscope and accessories | Endoscope and accessories | Same | ||
| Regulation Medical Specialty Panel | Gastroenterology/Urology | Gastroenterology/Urology | Gastroenterology/Urology | Same | ||
| General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Same | |||
| Intended Use | The Plasma Shield is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens | The Scope Antifogging System is intended use for this device is to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens. | DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the endoscope and laparoscope lens. | Similar | ||
| Technological Characteristics | 1) Mechanism of Action involves Cold Plasma | 1) Mechanism of Action involves heating and | 1) Mechanism of Action involves heating and | See NOTE 1 |
5
| | treatment
of
a
laparoscope lens.
2) Uses antifog solution.
3) Compact device that
enables intra-abdominal
visibility in laparoscopic
procedures.
4) Consists of a reusable
main system, disposable
part (sterile) with Anti-Fog
solution and sponge
applicator (both sterile).
5) Compatible with
laparoscopes of 5mm to
10mm. | dipping of distal end of
endoscope/laparoscope
into solution
2) Uses antifog solution
3) Compact device that
enables intra-abdominal
visibility in laparoscopic
procedures
4) Device is small, sterile,
and disposable with Anti-
Fog solution, sponge, and
trocar wipes (sterile).
5) Compatible with
laparoscopes of 5mm to
12mm. | dipping distal end
of
endoscope into solution.
2) Uses antifog solution.
3) Compact device that
enables intra-abdominal
visibility in laparoscopic
procedures.
4) Device is small, sterile,
and disposable with Anti-
Fog solution, sponge
applicator and trocar
wipes (sterile).
5) Compatible with
laparoscopes of 5mm to
10mm. | | | Li-Ion Battery pack of the
device) 12.6V and 0.5A
and DC power jack.
When the device is being
charged, it is turned off by
design. | | | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------|
| Performance
testing | Testing conducted with
live anesthetized pig. A
Stryker endoscopy
system was used with a
10mm and 5mm Stryker
scope, and Plasma Shield
was evaluated in a series
of experiments. Risk
analysis, Biocompatibility
(ISO 10993-1),
Sterilization,
Electrical and EMC based
on IEC 60601-1-2 and
60601-1, SW V&V, bench
testing, Life Expectancy
Verification,
Lens Fogging Validation,
usability simulated use
testing to demonstrate
effectiveness in a surgical
environment simulation
chamber. | Testing conducted with
live anesthetized pig. A
Karl Storz endoscopy
system was used with a
5mm and 10mm Storz
laparoscope. A series of
exploratory procedures
with 4 different Storz
laparoscope types were
used. Cleaning and
application of antifogging
solution to the scopes for
determination of fogging
prevention was performed
in several instances. Lens
Fogging Validation, Lens
Wiping of Debris
Validation, Life
Expectancy Validation,
Trocar Wiping Validation,
Biocompatibility, Electrical
Safety and EMC testing
were also conducted. | Testing conducted with
live anesthetized pig. A
Stryker 888 endoscopy
system was used with a
10mm and 5mm Stryker
laparoscope, and DHELP
was evaluated in series of
experiments with varying
temperatures and
surfactant concentrations
and by comparison to the
current defogging
methods. DHELP was
also used with 4 different
laparoscope types and on
Olympus, Stryker and
Storz camera systems to
make sure that it was
functionally compatible
with the most common
scopes and systems.
Temperature testing was
conducted on the DHELP
device. Risk Analysis and
biocompatibility testing
were also conducted. | See NOTE 2 | Electrical safety | Electrical safety and EMC
compatibility testing was
successfully conducted
on the Scope Antifogging
System. The system
complies with the IEC
60601-1-2 standard for
EMC.
The Scope Antifogging
system was electrical
safety tested under the
Standard IEC 60601-1. | Electrical safety and EMC
compatibility testing was
successfully conducted
on the Scope Antifogging
System. The system
complies with the IEC
60601-1-2 standard for
EMC.
The Scope Antifogging
system shall be electrical
safety tested under the
Standard IEC 60601-1. | No information available | |
| Clinical Studies | Not conducted | Not conducted | Not conducted | Similar | Materials,
Biocompatibility,
and Chemical
Safety | Biocompatible plastics
housing FDA approved
Anti-fog solution kit | Biocompatible plastics
housing
Anti-fog solution: Water,
Isopropanol, Ethanol,
Surfactant | Biocompatible plastics
housing FDA approved
ShurClens wound
cleaning surfactant | Similar |
| Compatibility
with the
environment and
other devices | Compatible with
endoscope and
laparoscope | Compatible with
endoscope and
laparoscope | Compatible with
endoscope and
laparoscope | Similar | Similarities to
Subject Device | NA | Intended Use and
compatibility with scopes
of 5mm to 12mm | Intended Use and
compatibility with scopes
of 5mm to 10mm | Similar |
| Energy used
and/or delivered | RF | Heat radiation | Heat (Infrared) radiation | See NOTE 3 | Weight | 1 kg max | No information available | 155 g | |
| Where used
(hospital, home,
ambulance, etc.) | Hospitals and/or surgery
centres on or by the order
of a physician | Hospitals and/or surgery
centres on or by the order
of a physician | Hospitals and/or surgery
centres on or by the order
of a physician | Same | Dimensions | 15107 cm | No information available | 976 cm | |
| Design
performance | Cell batteries at 11.1V
and a BMS (battery
management system) and
a Li-Ion battery charger | Cell Battery
No charger | Cell Battery
No charger | See NOTE 4 | Sterilization | ETO | Gamma Radiation | Gamma Radiation | See NOTE
2 |
| Operating
environmental
conditions | Temp: 10-40°C
Rel Humid: 20-80%
Atm Pres: 90-106 kPa | Temp: 5-40°C
Rel Humid: 15-95%
Atm Pres: 70-106 kPa | No information available | Similar | | | | | |
6
Discussion of Similarities and Differences between the proposed subject device and both the primary and reference predicate devices.
Comparison of intended use
Plasma Shield and predicate have identical indications for use. Plasma Shield and predicate have an identical primary intended use.
Technological Characteristic Comparison to Predicate
Comparison in Detail(s):
NOTE 1: Plasma Shield does not raise any additional risk to the patient when applied on commercially available laparoscopes comprised of stainless steel and glass. The subject device mechanism of action utilizes Cold Plasma while the predicate and reference device mechanism of action uses heat for introducing the fogging effect. Cold plasma treatment has a long (over 25 years) history of safe use in medical applications, i.e., sterilization of medical devices made of stainless steel and glass.
7
In addition to a disposable part, the subject device has a reusable part, which is not the case of the predicate and reference devices. This fact raises no additional safety concern since the reusable part was fully validated for cleaning and is fully in compliance with the TIR30 reusable standard requirements. The reusable device is covered by a sterile drape in-between use.
Cleaning Validation:
Manual cleaning process validation for the Plasma Shield reusable device, based on our Study, was performed and passed testing in accordance with TIR30.
Ingress tests:
A ingress test was performed for determining the viability of organisms after being exposed to the Single Use part of the Plasma Shield multiple times, at worst case system operation conditions, concluded that all test method acceptance criteria were met. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211, and 820.
NOTE 2: The following tests for Electrical and EMC based on IEC 60601-1-2 and 60601-1. SW V&V, and usability simulated use testing were conducted in addition to the special controls conducted on the predicate device:
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Minor" level of concern.
Usability Study Report
All the subjects succeeded to perform the device related tasks, with minimal number of requests for assistance and with no errors or inefficiencies. Following the summarized results, it can be concluded that the study success criteria was completely met, and that the Plasma Shield device can be easily operated by the potential end used safely according to the instructions manual.
Animal testing to demonstrate effectiveness in porcine model report: "Comparison of Plasma Shield vs. Clearify. Anti-fogging Devices, and Using Laparoscopy in Swine" was conducted and included in the submission.
The results of the risk analysis (according to ISO 14971) performed on Plasma Shield is detailed in the Plasma Shield Risk Analysis Report.
The subject device is categorized per Annex A of ISO 10993-1 as a medical device with no body contact. No further testing is deemed necessary. This difference has no impact on the device safety, since all device materials are well categorized, and biologically evaluated.
An ETO Sterilization validation (according to ISO 11135) was performed in the study titled EO Sterilization Validation for Clarity One of Plasmatica Ltd.
8
NOTE 3:
With reqards to the use of radio frequency. Plasma Shield does not raise any additional risk to the patient. Plasma Shield conforms to the requirements of IEC 60601-1-2 and 6061-2-2 sections 202.7 and 202.8.
NOTE 4:
The predicate, reference, and subject devices use reqular disposable batteries. The subject device, in addition, uses a Li-Ion battery charger, 12.6V and 0.5A and DC power jack. This fact raises no additional safety impact on the user. The Li-Ion battery is widely used in medical devices in a similar environment. It was tested and is fully compliant with the IEC 623166 standard under test report IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
Conclusions:
Comparison with the predicate and reference devices regarding functional characteristics shows that the subject device is intended for equivalent procedures as compared to the predicate and reference devices and makes use of similar functionality. The technological differences do not raise additional safety issues.
Substantial Equivalence Conclusion: The Sponsor has demonstrated through performance testing, design and features, and non-clinical testing, that the proposed subject device is substantially equivalent to the predicate and reference predicate devices.
The subject device Plasma Shield is Substantially Equivalent to the predicate and reference predicate devices.
7. Electrical and EMC Testing
The following testing supports testing information demonstrating safety and effectiveness of the Plasma Shield Device in the intended environment of use:
- FR Number 19-4 07/09/2014 ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, ● C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- FR Number 19-8 09/17/2018 IEC 60601-1-2- Edition 4.0 2014-02 Medical ● electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- FR Number 6-389 06/07/2021 IEC 60601-2-2 Edition 6.0 2017-03 Medical ● electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. Sections 202.7, 202.8 ONLY
9
8. Performance Testing:
Bench Performance testing was conducted on the proposed subject device to determine the performance and efficacy of the device. In addition, Performance testing – animal was conducted on the proposed subject device to compare the anti-fogging effect of Plasma Shield vs. Clearify™ devices during laparoscopy in swine. The study demonstrated the anti-fogging effect for both the proposed subject device and the predicate device.
Validation of product performance in compliance with the following product specification requirements was conducted on the proposed subject device:
- PRSJ.02: Scope's lens surface characteristics immediately post treatment (aka . activation): Plasma-induced surface activation should create a hydrophilic scope lens surface to reduce scope lens fogging as effectively as the predicate device, thereby demonstrating substantial equivalence.
- . PRS 4.3: The Plasma Shield interfaces with laparoscopes of 5mm and 10mm diameter, with 0-45 anqles.
- . PRS H.07: The system shall perform lens activation for scopes of 0, 30, and 45 angles, and different materials
The Plasma activated lenses of all tested scope are Super Hydrophilic and comparison to untreated lenses show highly improved contact angles. Product performance comply with the specification requirements. Therefore, plasma surface activation induced hydrophilicity reduces scope lens foqqing, conferring substantial equivalence with the predicate device working mechanism. Comparison with the predicate and reference devices regarding functional characteristics shows that the subject device is intended for equivalent procedures as compared to the predicate and reference devices and makes use of similar functionality.
Comparison of Proposed Subject Device Plasma Shield Vs. Clearify Predicate Device, Anti-Fogging Devices was conducted during Laparoscopy in Swine to compare the antifogging hydrophilicity effect of Plasma Shield vs. Clearify™ devices during laparoscopy in swine in order to demonstrate substantial equivalence.
Overall, both Plasma Shield and Clearify scope pretreatment received a higher score compared to none treated scope following video evaluation in all experimental conditions tested. These suggest that pretreatment of the scope with Plasma Shield or Clearify was more effective in preventing fog formation on the scope during laparoscopy compared to no treatment in these experimental settings. It can be concluded that Plasma Shield scope pretreatment is comparable to Clearify in its effectiveness to prevent fogging on the scope during laparoscopy and both are better in grading than no treatment, therefore demonstrating substantial equivalence between the devices.
9. Usability Studies
Usability Testing was conducted on the proposed subject device as per IEC 62366-1:2015, per FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" February 2016 and ANSI/AAMI NS4 2013 (R)2017. In addition, the proposed subject device is in compliance with the IEC 60601-1-6 - Collateral Standard -Usability test standard.
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10. Sterilization and Product Shelf Life
The proposed subject device is composed of a reusable part (RP) and disposable part (DP). The DP is sealed and the sterile part contains electrodes intended to deliver the plasma to the scope. The following validations have been conducted on the proposed subject device:
| Test Name | Main
standard/guideline | Essence | DP
level | RP
level | System
level |
|-------------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------|-------------|-------------|-----------------|
| Sterilization
validation | ISO 11135 | Conduct testing to ensure compliance to sterilization standard (ETO) | ✓ | | |
| Packaging
validation DP | ISO 11607-1 | Conduct packaging integrity, storage and transportation tests per appropriate standards | ✓ | | |
| Shelf-life
validation | ASTM F 1980:2016 | Conduct shelf-life tests per appropriate standard to verify required device shelf life. | ✓ | | |
| Packaging,
shipping and
environment | ASTM D4169-16
ASTM D4332-14 | Shipping performance and environmental testing | ✓ | ✓ | |
11. Product Cleaning/Disinfection Information
The proposed subject device is composed of a reusable part (RP) and disposable part (DP). The RP cleaning validation was performed to validate the cleaning process for the entire external surface of the device.
12. Software information:
Software verification and validation testing were conducted and supported by documentation according to the FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Based on FDA Software level of concern, the subject device is classified as "Minor" level of software concern.
The details about the software were clearly demonstrated in the software documentation and the risks related to the software products were mitigated
13. Risk Analysis
The proposed subject Plasma Shield Device complies with the ISO 14971: 2019 Medical devices - Application of risk management to medical devices" test standard. The testing ensures that the proposed subject device "Plasma Shield" meets the appropriate safety and effectiveness requirements.
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14. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the proposed subject Plasma Shield Device in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlines Electrical, Mechanical and Environmental Performance requirements.
- IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or . other non-acid electrolytes – Safety requirements for portable sealed secondary cells. and for batteries made from them, for use in portable applications – Part 2: Lithium systems
- ISO 11607-1: 2019 Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices Part 2: ● Validation requirements for forming, sealing and assembly processes
- . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- . ASTM F1886/F1886M - 2016 - Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- . FR Number 14-482 06/27/2016 ASTM F88/F88M-15- Standard Test Method for Seal Strength of Flexible Barrier Materials
- . ASTM F1140/ F1140M-13 (2020) Standard Test Methods for Packages Internal Pressurization Failure Resistance of Unrestrained
- ASTM F1929-15 - Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F3039-15 Standard Methods in Nonporous Packaging or Flexible Barrier ● materials by Dye Penetration
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers ● and Systems. Sections 14, 15 NOT APPLICABLE
- . ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process **Additional compliance to US-FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" of 4th September 2020.
- . ISO 15223-1: 2016 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
- AAMI TIR12:2020 Designing, testing, and labeling reusable medical devices for . reprocessing in health care facilities: A guide for medical device manufacturers
- . AAMI TIR30:2011/(R)2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that the proposed subject Plasma Shield Device tested met all relevant requirements of the aforementioned tests.
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Conclusions:
The design, characteristics, and performance of the proposed subject Plasma Shield device substantiates that the device is working as intended (use prior to and during endoscopic and laparoscopic procedures to prevent the fogging of the scope lens).
The proposed subject Plasma Shield Device is substantially equivalent to both its primary predicate device and the reference predicate device.