(17 days)
DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
DELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
The Defogging Endoscopic Lens Protector (D.E.L.P.) is a small, sterile, disposable, multi-function device. It is designed to store and apply anti-fog surfactant solutions to the distal lens of endoscopes. This is intended to reduce fogging on endoscopes by applying anti-fog solution to the distal lens.
The provided document describes two devices, D.H.E.L.P. (Defogging Heated Endoscopic Lens Protector) and D.E.L.P. (Defogging Endoscopic Lens Protector). The initial section primarily focuses on D.H.E.L.P. and its performance assessment, while later sections introduce D.E.L.P. and state that its functionality and compatibility were tested in trials conducted with the D.H.E.L.P. device. The performance criteria and study details are primarily related to D.H.E.L.P.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with specific performance thresholds. Instead, the performance assessment aims to demonstrate "equivalence to any other conventional method evaluated." The implicit acceptance criterion is that the DHELP device performs at least as well as, or equivalently to, other conventionally used anti-fogging methods for endoscopes.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Prevention of fogging during endoscopic/laparoscopic procedures | "DHELP's performance was equivalent to any other conventional method evaluated." |
| Functional compatibility with various scopes and camera systems | DHELP was "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." |
| Maintaining solution above body temperature (for D.H.E.L.P.) | "DHELP maintains this solution above body temperature for over 4 hours." (This is stated as a feature intended to reduce fogging better, implying it contributes to the overall performance.) |
| Biocompatibility standards met | "Meets Biocompatibility standards: Yes" for D.H.E.L.P. and predicate devices. |
| No new issues of safety and effectiveness | "Our evaluation concluded that D.H.E.L.P raises no new issues of Safety and effectiveness." and "Our evaluation concluded that D.E.L.P raises no new issues of Safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that DHELP testing was conducted "with a live anesthetized pig."
- It also states that DHELP was used with "4 different laparoscope types" (which could refer to the number of types used in the test, not necessarily the count of individual scopes) and "on Olympus, Stryker and Storz camera systems."
- The specific number of times the device was used on the pig, or the number of trials conducted to establish "equivalent" performance, is not specified.
- Data Provenance: The study was conducted in a laboratory setting ("live anesthetized pig"). There's no indication of country of origin for the data beyond the applicant's address in the USA. The study appears to be prospective in nature, as it describes a specific testing methodology for the DHELP device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications to establish ground truth for the performance assessment. The conclusion of "equivalence" seems to be based on the internal evaluation of the manufacturer.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. Decisions on "equivalence" appear to be made internally by the evaluators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described involves a device comparison against "current defogging methods" rather than assessing human reader performance with and without AI assistance. The device itself is an anti-fogging tool, not an AI diagnostic aid for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
The concept of "standalone (algorithm only)" is not applicable here as the device is a physical medical tool designed to prevent fogging, not a software algorithm. The performance assessment describes the functional performance of the physical device.
7. The Type of Ground Truth Used
The ground truth or reference standard for "equivalence to any other conventional method evaluated" and "prevent fogging" is implicitly expert observation and assessment during the live anesthetized pig study and potentially comparative qualitative assessment against predicate devices. There is no mention of pathology, outcomes data, or a formal expert consensus process.
8. The Sample Size for the Training Set
This question is not applicable. The DHELP and DELP devices are physical tools, not AI algorithms that require a training set. The descriptions relate to the testing of the final physical product.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a physical medical device.
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K062779 Exhibit 3
Revised 510(k) Summary
OC7 - 5 2006
Prepared: 215 August 2006
与
| 1. Applicant & Co-SpecificationDeveloper: | New Wave Surgical Corporation625 Jackson Ave Suite ABronx ,NY 10455 USATel #: 866-586-8883Fax:#: 866-586-6793 |
|---|---|
| SubmitterAddress | New Wave Surgical Corporation625 Jackson Ave Suite ABronx ,NY 10455 USATel #: 866-586-8883Fax:#: 866-586-6793 |
| Trade/proprietary Name | Defogging Heated Endoscope LensProtector |
| Common Names | Endoscope Anti- fogging Device |
| Classification name | Endoscope and/or Accessories |
| Classification number | 21CFR 876.1500 |
Legally marketed devices to which we are claiming equivalence
The different components of the DHELP device are functionally equivalent to the following supplies and devices:
Predicate devices using sterile antifog solutions in laparoscopic procedures:
| Endoscopic Anti Fog Device (Mister Clear) | 510k Number K993604 |
|---|---|
| Clear-It Anti-Fog Solution | 510k Number K022826 |
| ClearField Anti-Fog Sterile Wipe | 510k Number K974454 |
Predicate devices that defog the laparoscope by warming the scope in a heated solution:
| Applied Medical's Scope Warmer | 510k Number K931895 |
|---|---|
| Stryker's Scope Warmer | 510k Number K053311 |
| Deroyal Industries, Inc Defogger | 510k Number K982465 |
| OR Solution Scope Holder | 510k Number K051979 |
Predicate devices that are disposable and use batteries to power an electrical resistance heating mechanism:
Surgical Medical Device Cautery
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510K Number K023506
Predicate devices that are battery operated and disposable:
The following battery-operated device is used for laparoscopic surgeries and is disposable; much like DHELP is a small device containing batteries that is disposed after every laparoscopic surgery.
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Buffalo Filter's LapEvac Circon Surgiflex Wave Suction-Irrigator System
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510k Number K052797 510k Number K992126
| Comparison Table:Characteristicand Material | D.H.E.L.P | Clear-It Anti-Fog Solution(K)022826 | DeroyalIndustries,Inc Defogger(K)982465 | ORSolutionScopeHolder(K)051979 | Stryker'sScopeWarmer(K)053311 |
|---|---|---|---|---|---|
| Intended Use | DHELP isintended to beused prior toand duringendoscopicandlaparoscopicprocedures topreventfogging of thescope lens for5 mm and 10mm scopes | Clear-It Anti-Fog Solution isindicated for usein the sterilesurgical arena toeliminatecondensationfromendoscopiclenses,microscopelenses, gogglesand otherdevices thatare likely to fog. | Is usedduringendoscopic,laparoscopic,gastroscopicandarthroscopicprocedures topreventfogging ofendoscopelens | Isdesignedto holdoptical endof variousendoscopes abovethe warmsolution topreventfogging orwetting ofthe scopeeyepiece. | Is intendedto be used,prior to andduring theseprocedures,to heatendoscopesso as tominimizefogging ofthe scope. |
| Solution | FDA approvedShurClens, awoundcleaningsurfactant | Water,IsopropylAlcohol,Sodium AlcoholEther Sulfate,and AmmoniumDodecylbenzene | Surfactant inwater andisopropylalcohol | N/A | SodiumAcetate |
| Sponge | Yes | Yes | Yes | N/A | N/A |
| Mechanism ofAction | Heating anddipping distalend ofendoscope intosolution | Wiping distalend ofendoscope withsolution usingsponge | Wiping distalend ofendoscopewith solutionusing sponge | Heating | Heating |
| Sterility | Sterile | Sterile | Sterile | Sterile | Sterile |
| Reusable/Disposable | Disposable | Disposable | Disposable | Disposable | Reusable |
| MeetsBiocompatibilitystandards | Yes | N/A | Yes | Yes | Yes |
. . . .
..
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:
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Device Description:
The Defogging Heated Endoscopic Lens Protector (D.H.E.L.P.) is a small, sterile, Into Deloging maintains this solution above body temperature for over 4 hours. This is intended to reduce fogging better than other anti-fog methods by combining both heat and the antifog solution.
Intended Use:
DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
Assessment of Performance:
DHELP testing was conducted with a live anesthetized pig. A Stryker 888 endoscopy system was used with a 10mm and a 5mm Stryker laparoscope, and DHELP was evaluated in a 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 DHELP device. Risk Analysis and biocompatibility testing has also been conducted.
Conclusion:
DHELP's performance was equivalent to any other conventional method evaluated. Our evaluation concluded that D.H.E.L.P raises no new issues of Safety and effectiveness.
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Revised 510(k) Summary
Prepared: August 21st, 2006
| 1. Applicant & Co-SpecificationDeveloper: | New Wave Surgical Corporation625 Jackson Ave Suite ABronx ,NY 10455 USATel #: 866-586-8883Fax:#: 866-586-6793 |
|---|---|
| Submitter | New Wave Surgical Corporation |
| Address | 625 Jackson Ave Suite ABronx ,NY 10455 USATel #: 866-586-8883Fax:#: 866-586-6793 |
| Trade/proprietary Name | Defogging Endoscope Lens Protector |
| Common Names | Endoscope Anti- fogging Device |
| Classification name | Endoscope and/or Accessories |
| Classification number | 21CFR 876.1500 |
Legally marketed devices to which we are claiming equivalence
The different components of the DELP device are functionally equivalent to the following supplies and devices:
Substantial Equivalence:
The different components of the DELP device are functionally equivalent to the following supplies and devices:
Predicate devices using sterile antifog solutions in laparoscopic procedures:
| Endoscopic Anti Fog Device (Mister Clear) | 510k Number K993604 |
|---|---|
| Clear-It Anti-Fog Solution | 510k Number K022826 DGRNI |
| ClearField Anti-Fog Sterile Wipe | 510k Number K974454 |
| Deroyal Industries, Inc Defogger | 510k Number K982465 ULDB |
Device Description:
The Defogging Endoscopic Lens Protector (D.E.L.P.) is a small, sterile, disposable, multi-function device. It is designed to store and apply anti-fog surfactant solutions to the distal lens of endoscopes. This is intended to reduce fogging on endoscopes by applying anti-fog solution to the distal lens.
Intended Use:
DELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens
.
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| D.E.L.P | Clear-It Anti-FogSolution(K)022826 | DeroyalIndustries, IncDefogger(K)982465 | |
|---|---|---|---|
| Characteristic andMaterial | |||
| Intended Use | DELP is intendedto be used prior toand duringendoscopic andlaparoscopicprocedures toprevent fogging ofthe scope lens | Clear-It Anti-FogSolution is indicatedfor use in the sterilesurgical arena toeliminatecondensation fromendoscopic lenses,microscope lenses,goggles and otherdevices thatare likely to fog | Is used duringendoscopic,laparoscopic,gastroscopic aarthroscopicprocedures toprevent foggingendoscope lens |
| Solution | FDA approvedShurClens, awound cleaningsurfactant | Water, IsopropylAlcohol, SodiumAlcoholEther Sulfate, andAmmoniumDodecylbenzene | Surfactant in waterand isopropylalcohol |
| Sponge | Yes | Yes | Yes |
| Mechanism of Action | Dipping distal endof endoscope intosolution | Wiping distal end ofendoscope withsolution usingsponge | Wiping distal endof endoscope withsolution usingsponge |
| Size of endoscopes usedfor or accommodated bydevice | 5mm and 10mm | 5mm,10mm and allother Sizes | 5mm,10mm and allother sizes |
| Sterility | Sterile | Sterile | Sterile |
| Reusable/Disposable | Disposable | Disposable | Disposable |
| Meets Biocompatibilitystandards | Yes | N/A | Yes |
| Level of bio-compatibility | Externalcommunicatingdevice(Tissue/bone/Dentrincommunicating ) | Externalcommunicatingdevice (Tissue/bone/Dentrincommunicating ) | Externalcommunicatingdevice(Tissue/bone/Dentrincommunicating ) |
| Duration of bio-compatibility | Limited | Limited | Limited |
: .
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Assessment of Performance:
The functionality and compatibility of the main DELP components have been tested in trials conducted with the DHELP device. DELP is manufactured with the same stainless steel reservoir, the same ShurClens surfactant solution, the same white-balancing sponge, the same type of rubber valve, the same type of microfiber, and the same type of foam used in DHELP. All of these components functioned well in tests with DHELP and werc compatible with a wide range of scopes.
DHELP testing was conducted with a live anesthetized pig. A Stryker 888 endoscopy system was used with a 10mm and a 5mm Stryker laparoscope, and DHELP was evaluated in a 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 DHELP device. Risk Analysis and biocompatibility testing is also been conducted.
Conclusion:
DELP's performance was equivalent to any other conventional method evaluated. Our evaluation concluded that D.E.L.P raises no new issues of Safety and effectiveness.
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its body, representing the department's services. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
New Wave Surgical Corporation % Ms. Erin Sparnon Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462
Re: K062779
Trade/Device Name: Defogging Heated Endoscopic Lens Protector (D.H.E.L.P) and Defogging Endoscopic Lens Protector (D.E.L.P) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, KOG Dated: September 15, 2006 Received: September 18, 2006
OCT - 5 2006
Dear Ms. Sparnon:
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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Erin Sparnon
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buchup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Not Assigned as of now
Device Name: Defogging Heated Endoscopic Lens Protector (D.H.E.L.P)
Indications for Use:
DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
Prescription Use_X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR
Page 1 of 1
Obalare Bucheno for mym
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062779
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Indications for Use
510(k) Number (if known): Not Assigned as of now
Device Name: Defogging Endoscopic Lens Protector (D.E.L.P)
Indications for Use:
DELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
!
Page 1 of 1
Barbara Brichum
(Division Sign-Ont) Division of General, Restorative, and Neurological Devices
510(k) Number K062779
§ 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.