(54 days)
No
The description focuses on the optical and mechanical aspects of a rigid endoscope and does not mention any AI or ML capabilities.
Yes
The device's intended use explicitly states it is for "diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" states that the device is "intended to be used by surgeons in diagnostic and therapeutic procedures". Additionally, the "Device Description" section notes that the laparoscopes are used "to view a patient's internal anatomy for examination, diagnosis and therapy".
No
The device description clearly states that the O-Mec Laparoscopes are "rigid endoscopes" and "slender, tubular optical instruments," which are physical hardware components. The summary also details non-clinical testing related to the physical properties and performance of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health. They perform tests outside the body.
- Device Description: The O-Mec Laparoscopes are described as rigid endoscopes used to view a patient's internal anatomy during laparoscopic procedures. They are inserted into the body to provide a visual examination.
- Intended Use: The intended use is for surgeons to perform diagnostic and therapeutic procedures within the abdominal cavity by directly viewing the internal anatomy.
The device is used for direct visualization inside the body, not for testing samples taken from the body. This clearly places it outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The O-Mec Laparoscopes 690 Series (Models, 90-331000H, 690-300500H, 690-300500H, are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are rigid endoscopes that are used to view a patient's internal anatomy for examination, diagnosis and therapy during laparoscopic procedures. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are available in two sizes: 5mm or 10mm diameters, with either 0° or 30° directions of view. O-Mec laparoscope provides a high definition image and can correct chromatic aberration in the 400-900nm wavelength range.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are delivered non-sterile and are reusable and fully autoclavable. O-Mec laparoscopes must be cleaned according to the Instructions of Use before each use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
abdominal cavity, body cavities, hollow organs, and canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Functional Performance Tests: Marking, Surface & Edges, Connection, Dimensions, Cleanliness, Aperture and Center Focus, Evenness of Illumination, Image Consistency and Depth of Field, Image Focus and Color, Reflection and Runout, FOV/DOV, MTF, Transmission / Vignetting, Distortion, Runout. All met acceptance criteria.
Sterilization/Cleaning Validation Studies:
- Manual/Mechanical Cleaning Validation GLP Report: Cleaning validation was performed for recommended procedures and Enzol detergent using Hemoglobin Test, Micro BCA Protein Test, and MEM Elution Test. The cleaning study was successful in showing the reduction of physical markers, providing evidence that laparoscopes can be cleaned effectively using the instructions provided.
- Simulated Use Cycles Final Report: Six simulated use cycles were performed, each included soiling, cleaning, and sterilization procedures, and article oiling. No soil was observed on any of the articles.
- Steam Sterilization Validation Final Report: Test article was evaluated to a sterility assurance level (SAL) of
§ 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.
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June 22, 2020
OMEC Medical, Inc. % Ms. Yolanda Smith Sr. Regulatory Consultant Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114 Re: K201151 Trade/Device Name: O-Mec Laparoscopes 690 Series (Models 690- 331000H, 690-300500H, 690-300530H)
Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 14, 2020 Received: April 29, 2020
Dear Ms. Smith:
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.
1
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 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 medical devices and radiation-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,
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) K201151
Device Name
O-Mec Laparoscopes 690 Series (Models, 690-331000H, 690-331030H, 690-300500H, 690-300530H)
Indications for Use (Describe)
The O-Mec Laparoscopes 690 Series (Models, 90-331000H, 690-300500H, 690-300500H, are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.
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
510(k) Summary
1. Submitter Information
| Company Name: | OMEC Medical Inc. |
|---|---|
| Company Address: | 2370 Qume Drive, Suite A |
| San Jose, CA 95131 | |
| Telephone: | 408-667-5307 |
| Fax: | 408-436-5557 |
| Contact Person: | Ms. Claire Nippress |
| Email: | clairen@omectech.us |
2. Correspondent Information
| Contact: | Ms. Yolanda Smith |
|---|---|
| Sr. Regulatory Consultant | |
| Smith Associates | |
| Address: | 1468 Harwell Ave |
| Crofton, MD 21114 | |
| Phone: | (410)451-0639 |
| Ysmith9746@fdaconsultants.com |
3. Date Prepared: June 17, 2020
4. Device Name
| Classification Name: | Laparoscope, General & Plastic Surgery |
|---|---|
| Common/Usual Name: | Laparoscope |
| Proprietary Name: | O-Mec Laparoscopes 690 Series (Models 690-331000H, 690-331030H, 690-300500H,690-300530H) |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Device Class: | Laparoscopes 21 CFR 876.1500 |
| Reviewing Panel: | General & Plastic Surgery |
| Basis for Submission: | New device 510k |
5. Predicate Device
Legally Marketed Equivalent Device
| | Manufacturer | Brand Name | 510(k)
Number |
|-----------|---------------------------|-------------------------------|------------------|
| Primary | Stryker Endoscopy | Stryker Bariatric Laparoscope | K993045 |
| Reference | Schoelly Fiberoptics GmbH | Schoelly Laparoscope | K143221 |
| Reference | Stryker Corporation | Stryker Laparoscope | K910132 |
6. Device Description
4
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are rigid endoscopes that are used to view a patient's internal anatomy for examination, diagnosis and therapy during laparoscopic procedures. An endoscope is a slender, tubular optical instrument used as a viewing system for examining an inner part of the body. The inside of the endoscope contains a series of lenses that transmit the endoscopic image, which is illuminated by an external light source.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are available in two sizes: 5mm or 10mm diameters, with either 0° or 30° directions of view. O-Mec laparoscope provides a high definition image and can correct chromatic aberration in the 400-900nm wavelength range.
O-Mec laparoscopes 690 Series Models 690- 331000H, 690-331030H, 690-300500H, 690-300530H are delivered non-sterile and are reusable and fully autoclavable. O-Mec laparoscopes must be cleaned according to the Instructions of Use before each use.
| Catalog No. | Working Length | Maximum Width of
Inserted Portion | Direction of View |
|-------------|----------------|--------------------------------------|-------------------|
| 690-331000H | 331mm | 10.1mm | 0° |
| 690-331030H | 334mm | 10.1mm | 30° |
| 690-300500H | 301mm | 5.5mm | 0° |
| 690-300530H | 303mm | 5.5mm | 30° |
Table 1: Model Specifications - 690 Series
7.Indications for Use
The O-Mec Laparoscopes 690 Series (Models, 90-331030H, 690-331030H, 690-300530H) are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
8. Comparison of Technical Characteristics
The table below lists the comparison of the indications for use and technological characteristics of the subject and predicate device.
| Parameter | Subject Device | Primary
Predicate Device | Reference
K143221 | Comments |
|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| 510(k)
Number | K201151 | K993045 | K143221 | |
| Brand Name | 690 Series | Stryker Bariatric
Laparoscope | Schoelly
Laparoscope | |
| Parameter | SubjectDevice
K201151 | Predicate Device
K993045 | Predicate Device
K143221 | Comments |
| Regulation
Number | 876.1500 | 876.1500 | 876.1500 | Same |
| Regulation
Name | Laparoscope, general
& Plastic Surgery | Endoscope and
Accessories | Endoscope and
Accessories | Same |
| Product Code | GCJ | GCJ | GCJ | Same |
| Indications for
Use | The O-Mec 690 Series
Laparoscopes (690-
331000H, 690-
331030H, 690-
300500H, 690-
300530H) are intended
to be used by surgeons
in diagnostic and
therapeutic
procedures.
Laparoscopic minimally
invasive procedures
are performed in the
abdominal cavity by
means of small skin
punctures that allow
the insertion of the
laparoscope and
laparoscopic
instruments. | Laparoscopes are
intended to be used
by surgeons in
diagnostic and
therapeutic
procedures.
Laparoscopic
minimally invasive
procedures are
performed in the
abdominal cavity by
means of small skin
punctures that allow
the insertion of the
laparoscope and
laparoscopic
instruments. This
includes, but is not
limited to such uses
as gallbladder and
appendix removal,
hernia repair, gastric
bypass, laparoscopic
Nissen and
examination of the
abdominal cavity,
appendix, gallbladder
and liver. | The Schoelly
Laparoscope is
indicated for
examination of
body cavities,
hollow organs,
and canals, and
using additional
accessories, to
perform various
diagnostic and
therapeutic
procedures. | Similar |
| Principle of
Operation | Rigid, tubular, optical
instrument through
an incision in the
abdominal wall, used
to examine organs
inside the abdomen. | Rigid, tubular, optical
instrument through
an incision in the
abdominal wall, used
to examine organs
inside the abdomen. | Rigid, tubular,
optical instrument
through an
incision in the
abdominal wall,
used to examine
body cavities,
hollow organs,
and canals. | Similar |
| Models Feature Comparison | | | | |
| Parameter | Subject Device
K201151 | Predicate Device
K993045 | Predicate Device
K143221 | Comments |
| Catalog no | 690-331000H | 502-537-010 | 11.0031a | |
| Working
Length | 331mm | 300mm | 344mm | Similar |
| Maximum
Width of
inserted
Portion | 10.1mm | Ø10.0mm | 10.0mm | Similar |
| Direction of
view | 0° | 0° | 0° | Same |
| Catalog no | 690-331030H | 502-537-030 | 11.0043a | |
| Working
Length | 334mm | 300mm | 344mm | Similar |
| Maximum
Width of
inserted
Portion | 10.1mm | Ø10.0mm | 10.0mm | Similar |
| Direction of
view | 30° | 30° | 30° | Same |
| Catalog no | 690-300500H | 502-937-010 | N/A | |
| Working
Length | 301mm | 300mm | 312mm | Similar |
| Maximum
Width of
inserted
Portion | 5.5mm | Ø5.5mm | 5.0mm | Similar |
| Direction of
view | 0° | 0° | 0° | Same |
| Catalog no | 690-300530H | 502-937-030 | N/A | |
| Working
Length | 303mm | 300mm | 312mm | Similar |
| Maximum
Width of
inserted
Portion | 5.5mm | Ø5.5mm | 5.0mm | Similar |
| Direction of
view | 30° | 30° | 30° | Same |
| Optical System | | | | |
| Parameter | Subject Device
K201151 | Predicate Device
K993045 | Predicate Device
K143221 | Comments |
| Depth of Field | 25mm to 150mm | N/A | N/A | Information
not available |
| Field of View | 75° | N/A | Wide angle | Only wide
angle
referenced |
| Correct
Chromatic
Aberration | 400-900nm
wavelength range | N/A | N/A | Reference
predicate
K910132 |
| Material Choices | | | | |
| Body
Assembly | Stainless Steel 304
Stainless Steel 316L
Optical Glass
Sapphire
Epoxy Glue | Stainless Steel
Optical glass | Stainless Steel
304
Optical Glass | Similar |
| Eyepiece
Eyepiece is
standard:
ISO/TS
18339:2015-
11
Endotherapy
devices -
Eyepiece cap
and light guide
connector | Polyetheretherketone
(PEEK) | Yes | Yes | Same |
| Accessories | | | | |
| Cable Adapter
Compatibility | Wolf Adapter
Storz Adapter
ACMI Adapter | N/A | N/A | |
| Non- sterile
Delivered in
non-sterile
condition.
Needs to be
sterilized
before each
use. | Yes | Yes | Yes | Same |
| Autoclavable | Yes | Yes | Yes | Same |
| Reusable/
Reprocessable | Yes | Yes | Yes | Same |
Table 2: Comparator table for Subject Device
5
6
7
8
Reference Predicate
K910132 is included as a reference predicate for the 400-900nm wavelength. The subject and reference device have very minor modifications to enhance near infrared images.
9. Summary of Non-Clinical Testing
The following performance data were provided in support of the substantial equivalence determination.
Table 3: Summary Table of Non-Clinical Testing
| Category | Test Title | Evaluation | Test Criteria | Results |
|---|---|---|---|---|
| Functional | ||||
| Performance | Laparoscope | |||
| Performance Test | Marking | Met acceptance criteria | ||
| Surface & Edges | Met acceptance criteria | |||
| Connection | Met acceptance criteria | |||
| Dimensions | Met acceptance criteria | |||
| Cleanliness | Met acceptance criteria | |||
| Aperture and Center | ||||
| Focus | Met acceptance criteria | |||
| Evenness of | ||||
| Illumination | Met acceptance criteria | |||
| Image Consistency | ||||
| and Depth of Field | Met acceptance criteria | |||
| Image Focus and | ||||
| Color | Met acceptance criteria | |||
| Reflection and Runout | Met acceptance criteria | |||
| FOV/DOV | Met acceptance criteria | |||
| MTF | Met acceptance criteria | |||
| Transmission / | ||||
| Vignetting | Met acceptance criteria | |||
| Distortion | Met acceptance criteria | |||
| Runout | Met acceptance criteria | |||
| Sterilization/ | ||||
| Cleaning | ||||
| Validation | ||||
| Studies | Manual/Mechanical | |||
| Cleaning Validation | ||||
| GLP Report | Cleaning validation | |||
| was performed for | ||||
| recommended | ||||
| procedures and Enzol | ||||
| detergent | ||||
| Hemoglobin Test | ||||
| Micro BCA Protein | ||||
| Test | ||||
| MEM Elution Test | AAMITIR30:2011 | The cleaning study was | ||
| successful in showing | ||||
| the reduction of the | ||||
| physical markers. | ||||
| This provides evidence | ||||
| that laparoscopes can | ||||
| be cleaned effectively | ||||
| using the instructions | ||||
| provided. | ||||
| Simulated Use | ||||
| Cycles Final Report | Six simulated use | |||
| cycles were | ||||
| performed. Each cycle | ||||
| included soiling, | ||||
| cleaning and | AAMITIR30:2011 | No soil was observed on | ||
| any of the articles. | ||||
| Category | Test Title | Evaluation | Test Criteria | Results |
| sterilization | ||||
| procedures | ||||
| Article oiling | ||||
| Manual Cleaning | ||||
| procedure | ||||
| Sterilization | ||||
| Steam Sterilization | ||||
| validation Final | ||||
| Report | Test article was | |||
| evaluated to a sterility | ||||
| assurance level (SAL) | ||||
| of $≤10-6$ | ANSI/AAMI/ISO | |||
| 17665- | ||||
| 1:2006/®2013, | ||||
| Annex D and the | ||||
| validation | ||||
| approach outlined | ||||
| in ANSI/AAMI/ISO | ||||
| 14937:2009®2013, | ||||
| Annex D | ||||
| (Approach 3) | Results validated following | |||
| sterilization set points: |
Sterilizer Type: Prevacuum
Preconditioning Pulses: 4
Temperature: 132°C Full
Cycle Time: 4 minutes
Dry Time: 40 minutes Test
Article Configuration:
Individually wrapped in
two layers of 1-ply
polypropylene wrap
(Halyard Health H200
- 510(k)
K082554) using sequential
envelope folding
techniques Load
Configuration: One 20
pound tray filled with
miscellaneous stainless
steel dunnage was placed
above the test article in
the sterilizer |
| Electrical
Safety | Medical electrical
equipment Part 1
general
requirements for
basic safety and
essential
performance | Clause 5.7 Humidity
Preconditioning
Treatment
Clause 5.9.2
Determination of
Accessible parts
Clause 7.1.2 Legibility
of Marking Clause
7.1.3 Marking
Durability
Clause 8.7 Leakage
current
Clause 8.8.3
Dielectric
strength test | IEC 60601-1
2005+A1:2012 | Pass |
| | Medical
electrical
equipment Part 2:
particular
requirement for
the basic safety
and essential
performance of
endoscopic
equipment | | IEC60601-2-18 | Pass |
| Category | Test Title | Evaluation | Test Criteria | Results |
| | | Clause 11.1,. 1
w=Excessive
temperatures
Clause 15.3.2 Push
test
Clause 15.3.4.1 Drop
test
Clause 15.3.6
Mould stress relief
test | | |
| Hazard
Analysis | Medical devices -
Application of risk | | ISO 14971 2nd
Edition R 2010 | |
9
10
Clinical testing was not performed with this device.
management to medical devices
10. Conclusion
The subject device is similar and or same for technological features to the predicate devices with slight differences for working length and width of inserted portion. The differences introduce not new issues of safety.