(86 days)
The Smith & Nephew Vascular VideoEndoscope is indicated for use in subcutanous endoscopy, specifically for endocopically gaining access to, ligating and/or harvesting vessels within the subcutaneous and subfascial surgical planes in the lower extremities.
The proposed Smith & Nephew Vascular VideoEndoscope is designed in an "L" shaped configuration as to have the horizontal optical train and working channel as the part that is introduced into the leg and the vertical shaft as a handle. The connecting cables and tubing are conveniently located far from the leg to minimize any interference with the surgeon's hand movements. The function of the Smith & Neohew Vascular VideoEndoscope is to create and maintain a subfascially working space, provide visualization of the working space, and provide access to hand instruments to the working space. The attachments utilize the same locking feature located on the endoscope which allows the Smith & Nephew Vascular VideoEndoscope to be used as a multi-purpose device.
This document is a 510(k) summary for the Smith & Nephew Vascular VideoEndoscope. It focuses on demonstrating substantial equivalence to predicate devices, rather than performing a clinical study with detailed performance metrics and acceptance criteria for a new AI-powered diagnostic device. Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, and AI-related metrics is largely not available in this document.
However, I can extract the relevant information that is present and indicate where the requested information is absent based on the nature of this regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. This document is a 510(k) summary demonstrating substantial equivalence to predicate devices, not a study reporting specific performance metrics against pre-defined acceptance criteria for a new device. | The device is described as "substantially equivalent in design, materials of construction and function and intended use as to the Olympus Endoscopic System for Vessel Harvesting, Smith & Nephew's Images Endoscopes, and Ethicon's EndoPath Ultra Retractor and Vessel Dissector." |
2. Sample size used for the test set and the data provenance
Not available. This document does not describe a test set or data provenance in the context of device performance evaluation. It is a regulatory submission comparing a new device to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available. This document does not mention experts establishing ground truth for a test set.
4. Adjudication method for the test set
Not available. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not available. This document does not mention any MRMC study or AI assistance. The device described is a video endoscope, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an endoscope, not an algorithm.
7. The type of ground truth used
Not available. This document does not describe the establishment of a ground truth in the context of device performance.
8. The sample size for the training set
Not available. This document does not describe a training set.
9. How the ground truth for the training set was established
Not available. This document does not describe a training set or its ground truth establishment.
Summary of available information from the document:
- Device Name: Smith & Nephew Vascular VideoEndoscope
- Intended Use: For use in subcutaneous endoscopy, specifically for endocopically gaining access to, ligating, and/or harvesting vessels within the subcutaneous and subfascial surgical planes in the lower extremities.
- Predicate Devices:
- Basis for Clearance: Substantial equivalence to predicate devices in "design, materials of construction and function and intended use."
The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing the new device's technical characteristics and intended use to predicate devices, rather than conducting new clinical performance studies with detailed statistical analyses as would be required for a novel AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" surrounding it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2015
Smith & Nephew, Inc. Endoscopy Division Janice Haselton Regulatory Affairs Specialist 160 Dascomb Road Andover, MA 01810
Re: K012724
Trade/Device Name: Smith & Nephew Vascular VideoEndoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: LYK, FET Dated (Date on orig SE ltr): August 14, 2001 Received (Date on orig SE Itr): August 14, 2001
Dear Ms. Haselton,
This letter corrects our substantially equivalent letter of November 8, 2001.
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, 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
{1}------------------------------------------------
Page 2 -
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
NOV 0 82001
510(k) Number : Ko 12724
Device Name : Smith & Nephew Vascular VideoEndoscope
Indications for Use :
The Smith & Nephew Vascular VideoEndoscope is indicated for use in subcutanous endoscopy, The Smith & Nephew Vascular VideoEndosoops in mercesting vessels within the specifically for endooopleans gaming and surgical planes in the lower extremities.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109) (Optional Format 1-2-96)
Over-the-Counter _
Susan Walke
(Division Sign-Off) (Division of General, Restorative Division of ogical Devices
510(k) Number K012724
Smith & Nephew Vascular Video Endoscope Page 18 of 41 System
{3}------------------------------------------------
NOV 0 82001
Kol2724
Endoscopy Division
Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: 978-749-1000 Telefax: 978-749-1599
Smith - Nephew
510(k) Summarv Smith & Nephew Vascular VideoEndoscope Date Prepared:
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 8807.92.
A. Submitter
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810
B. Company Contact
Janice Haselton Regulatory Affairs Specialist
C. Device Name
Trade Name: Smith & Nephew Vascular VideoEndoscope Common Name: Vascular Endoscope Classification Name: Endoscope and/or Accessories
D. Predicate Devices
Olympus Endoscopic System for Vessel Harvesting K963184 Ethicon's EndoPath Ultra Retractor and Vessel Dissector K973139 Smith & Nephew's Images Endoscopes K971850
E. Description of Device
The proposed Smith & Nephew Vascular VideoEndoscope is designed in an "L" shaped configuration as to have the horizontal optical train and working channel as the part that is introduced into the leg and the vertical shaft as a handle. The connecting cables and tubing are conveniently located far from the leg to minimize any interference with the surgeon's hand movements. The function of the Smith & Neohew
Smith & Nephew Vascular Video Endoscope Page 40 of 41 System
{4}------------------------------------------------
Kci2724
Vascular VideoEndoscope is to create and maintain a subfascially working space, provide visualization of the working space, and provide access to hand instruments to the working space.
The attachments utilize the same locking feature located on the endoscope which allows the Smith & Nephew Vascular VideoEndoscope to be used as a multi-purpose device.
F. Intended Use
The Smith & Nephew Vascular VideoEndoscope is indicated for use in subcutanous endoscopy, specifically for endocopically gaining access to, ligating and/or harvesting vessels within the subcutaneous and subfascial surgical planes in the lower extremities.
G. Comparison of Technological Characteristics
The Smith & Nephew Vascular VideoEndoscope is substantially equivalent in design, materials of construction and function and intended use as to the Olympus Endoscopic System for Vessel Harvesting, Smith & Nephew's Images Endoscopes, and Ethicon's EndoPath Ultra Retractor and Vessel Dissector.
Janie Houston
anice Haselton Regulatory Affairs Specialist
§ 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.