Who can help prepare an FDA 510(k) submission like DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)

Q: Who is the manufacturer of DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)?

New Wave Surgical Corporation filed the 510(k) submission for DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) (K062779).

Q: What is the FDA product code for DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)?

GCJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)?

Endoscopic Anti Fog Device (Mister Clear) (K993604); Clear-It Anti-Fog Solution (K022826); ClearField Anti-Fog Sterile Wipe (K974454); Applied Medical's Scope Warmer (K931895); Stryker's Scope Warmer (K053311); Deroyal Industries, Inc Defogger (K982465); OR Solution Scope Holder (K051979); Surgical Medical Device Cautery (K023506); Buffalo Filter's LapEvac (K052797); Circon Surgiflex Wave Suction-Irrigator System (K992126).

K062779 · New Wave Surgical Corporation · GCJ · Oct 5, 2006 · Gastroenterology, Urology

Device Facts

Record ID	K062779
Device Name	DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP)
Applicant	New Wave Surgical Corporation
Product Code	GCJ · Gastroenterology, Urology
Decision Date	Oct 5, 2006
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended Use

DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

Device Story

D.H.E.L.P. and D.E.L.P. are sterile, disposable devices designed to prevent endoscope lens fogging during endoscopic and laparoscopic procedures. D.H.E.L.P. incorporates an electrical resistance heating mechanism powered by batteries to maintain an anti-fog surfactant solution (ShurClens) above body temperature for over 4 hours; D.E.L.P. is a non-heated version for storing and applying the same surfactant. The clinician dips the distal end of the endoscope into the device's reservoir to apply the solution. By combining heat and surfactant, the device reduces condensation on the lens, improving visualization for the surgeon. These devices are used in the OR by surgeons or surgical staff. Improved visualization assists in clinical decision-making during minimally invasive surgery, potentially reducing procedure time and improving patient outcomes by maintaining clear optical access.

Clinical Evidence

Bench testing and animal study conducted. D.H.E.L.P. evaluated in a live anesthetized pig model using Stryker 888 endoscopy system with 5mm and 10mm laparoscopes. Experiments compared D.H.E.L.P. against conventional defogging methods across varying temperatures and surfactant concentrations. Functional compatibility verified with Olympus, Stryker, and Storz camera systems. Biocompatibility and temperature testing performed. Results indicated performance equivalent to conventional methods.

Technological Characteristics

Disposable, sterile, multi-function devices. D.H.E.L.P. includes battery-powered electrical resistance heating; D.E.L.P. is non-heated. Materials include stainless steel reservoir, ShurClens surfactant, rubber valve, microfiber, and foam. Designed for 5mm and 10mm endoscopes. External communicating device (tissue/bone/dentin) with limited duration of contact. Biocompatibility standards met.

Indications for Use

Indicated for use in endoscopic and laparoscopic procedures to prevent fogging of the scope lens in patients undergoing such procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Endoscopic Anti Fog Device (Mister Clear) (K993604)
Clear-It Anti-Fog Solution (K022826)
ClearField Anti-Fog Sterile Wipe (K974454)
Applied Medical's Scope Warmer (K931895)
Stryker's Scope Warmer (K053311)
Deroyal Industries, Inc Defogger (K982465)
OR Solution Scope Holder (K051979)
Surgical Medical Device Cautery (K023506)
Buffalo Filter's LapEvac (K052797)
Circon Surgiflex Wave Suction-Irrigator System (K992126)

Related Devices

K150569 — LaparoVue · Buffalo Filter, LLC · Jun 10, 2015
K182080 — Scope Antifogging System · Xodus Medical, Inc. · Sep 19, 2018
K973558 — VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) · Ultracell Medical Technologies, Inc. · Nov 24, 1997
K982465 — DEROYAL INDUSTRIES, INC. DEFOGGER · Deroyal Industries, Inc. · Aug 11, 1998
K993604 — ENDOSCOPIC ANTI FOG DEVICE · Mectra Labs, Inc. · Mar 3, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ K062779 Exhibit 3 # Revised 510(k) Summary OC7 - 5 2006 Prepared: 215 August 2006 与 | 1. Applicant & Co-Specification Developer: | New Wave Surgical Corporation 625 Jackson Ave Suite A Bronx ,NY 10455 USA Tel #: 866-586-8883 Fax:#: 866-586-6793 | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Submitter Address | New Wave Surgical Corporation 625 Jackson Ave Suite A Bronx ,NY 10455 USA Tel #: 866-586-8883 Fax:#: 866-586-6793 | | Trade/proprietary Name | Defogging Heated 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 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 : 上一篇: : : : 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. : 上 : : {1}------------------------------------------------ Buffalo Filter's LapEvac Circon Surgiflex Wave Suction-Irrigator System . 510k Number K052797 510k Number K992126 | Comparison Table: Characteristic and Material | D.H.E.L.P | Clear-It Anti- Fog Solution (K)022826 | Deroyal Industries, Inc Defogger (K)982465 | OR Solution Scope Holder (K)051979 | Stryker's Scope Warmer (K)053311 | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | DHELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens for 5 mm and 10 mm scopes | Clear-It Anti- Fog Solution is indicated for use in the sterile surgical arena to eliminate condensation from endoscopic lenses, microscope lenses, goggles and other devices that are likely to fog. | Is used during endoscopic, laparoscopic, gastroscopic and arthroscopic procedures to prevent fogging of endoscope lens | Is designed to hold optical end of various endoscope s above the warm solution to prevent fogging or wetting of the scope eyepiece. | Is intended to be used, prior to and during these procedures, to heat endoscopes so as to minimize fogging of the scope. | | Solution | FDA approved ShurClens, a wound cleaning surfactant | Water, Isopropyl Alcohol, Sodium Alcohol Ether Sulfate, and Ammonium Dodecylbenzene | Surfactant in water and isopropyl alcohol | N/A | Sodium Acetate | | Sponge | Yes | Yes | Yes | N/A | N/A | | Mechanism of Action | Heating and dipping distal end of endoscope into solution | Wiping distal end of endoscope with solution using sponge | Wiping distal end of endoscope with solution using sponge | Heating | Heating | | Sterility | Sterile | Sterile | Sterile | Sterile | Sterile | | Reusable/Disposable | Disposable | Disposable | Disposable | Disposable | Reusable | | Meets Biocompatibility standards | Yes | N/A | Yes | Yes | Yes | . . . . .. . : {2}------------------------------------------------ #### 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. {3}------------------------------------------------ # Revised 510(k) Summary ### Prepared: August 21st, 2006 | 1. Applicant & Co-Specification Developer: | New Wave Surgical Corporation 625 Jackson Ave Suite A Bronx ,NY 10455 USA Tel #: 866-586-8883 Fax:#: 866-586-6793 | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | Submitter | New Wave Surgical Corporation | | Address | 625 Jackson Ave Suite A Bronx ,NY 10455 USA Tel #: 866-586-8883 Fax:#: 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 . {4}------------------------------------------------ | | D.E.L.P | Clear-It Anti-Fog Solution (K)022826 | Deroyal Industries, Inc Defogger (K)982465 | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Characteristic and Material | | | | | Intended Use | DELP is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens | Clear-It Anti-Fog Solution is indicated for use in the sterile surgical arena to eliminate condensation from endoscopic lenses, microscope lenses, goggles and other devices that are likely to fog | Is used during endoscopic, laparoscopic, gastroscopic a arthroscopic procedures to prevent fogging endoscope lens | | Solution | FDA approved ShurClens, a wound cleaning surfactant | Water, Isopropyl Alcohol, Sodium Alcohol Ether Sulfate, and Ammonium Dodecylbenzene | Surfactant in water and isopropyl alcohol | | Sponge | Yes | Yes | Yes | | Mechanism of Action | Dipping distal end of endoscope into solution | Wiping distal end of endoscope with solution using sponge | Wiping distal end of endoscope with solution using sponge | | Size of endoscopes used for or accommodated by device | 5mm and 10mm | 5mm,10mm and all other Sizes | 5mm,10mm and all other sizes | | Sterility | Sterile | Sterile | Sterile | | Reusable/Disposable | Disposable | Disposable | Disposable | | Meets Biocompatibility standards | Yes | N/A | Yes | | Level of bio- compatibility | External communicating device (Tissue/bone/ Dentrin communicating ) | External communicating device (Tissue/bone/ Dentrin communicating ) | External communicating device (Tissue/bone/ Dentrin communicating ) | | Duration of bio- compatibility | Limited | Limited | Limited | : . {5}------------------------------------------------ # 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ ### 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 {9}------------------------------------------------ #### 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