(17 days)
No
The device description and performance studies focus on physical methods (heating, anti-fog solution) to prevent lens fogging. There is no mention of AI, ML, image processing, or data analysis for decision-making or image enhancement.
No
The device is intended to prevent fogging of scope lenses during endoscopic and laparoscopic procedures, which is a maintenance function for the visualization equipment, not a therapeutic intervention on a patient.
No
Explanation: The device description states that DHELP and DELP are "intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens." This function is to maintain the clarity of the endoscope's view, which is a procedural aid, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is a "small, sterile, disposable, multi-function device" and mentions physical components like a stainless steel reservoir, rubber valve, microfiber, and foam. It also describes heating and applying a solution, which are physical actions performed by hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prevent fogging of the scope lens" during endoscopic and laparoscopic procedures. This is a functional purpose related to the imaging equipment used during a medical procedure, not a diagnostic test performed on a biological sample.
- Device Description: The device is described as a "Defogging Heated Endoscopic Lens Protector" and a "Defogging Endoscopic Lens Protector." Its function is to store and apply anti-fog solutions and potentially provide heat to the scope lens. This is a physical device used to maintain the clarity of the scope's view.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
The device is clearly intended to improve the visualization during a surgical or diagnostic procedure performed in vivo (within the body), not to perform a diagnostic test in vitro (outside the body).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, KOG
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.
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.
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
Not Found
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)
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.
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.
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.
K993604, K022826, K974454, K931895, K053311, K982465, K051979, K023506
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.
Not Found
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
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