OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT

K973232 · Olympus Winter & Ibe GmbH · GCJ · Nov 21, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973232
• Device Name: OLYMPUS SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY (SEPS) SYSTEM, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT
• Applicant: Olympus Winter & Ibe GmbH
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Olympus SEPS System is designed for subcutaneous endoscopy -- more specifically, for endoscopically gaining access to vessels (arteries veins, ducts, nerves) in subcutaneous and subfascial surgical planes in the lower extremities for endoscopic observation, diagnosis, and treatment.

Device Story

The Olympus SEPS System is an endoscopic surgical instrument set used for subfascial endoscopic perforating vein surgery. It provides visualization and access to vessels in the lower extremities. The system consists of endoscopes, hand instruments, and ancillary equipment. It is used by surgeons in an operating room setting to perform minimally invasive procedures. The device allows for direct visualization of the surgical site, enabling the surgeon to identify and treat perforating veins. By facilitating endoscopic access, the system aims to reduce surgical trauma compared to open procedures, potentially leading to improved patient outcomes and faster recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The system comprises endoscopes, hand instruments, and ancillary equipment designed for endoscopic access. It utilizes standard endoscopic visualization principles. Materials are consistent with medical-grade surgical instruments. The system is intended for use in a sterile surgical environment.

Indications for Use

Indicated for patients requiring endoscopic access to vessels (arteries, veins, ducts, nerves) in subcutaneous and subfascial surgical planes of the lower extremities for observation, diagnosis, and treatment.

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

• Olympus Subcutaneous Endoscopy System (K963184)
• Endoscopic Plastic/Reconstructive and Aesthetic Surgery Endoscopes (K950076)
• Endoscopic Plastic/Reconstructive and Aesthetic Surgery Hand Instruments (K950103)
• Olympus Ultrathin Ureteroscope (K951855)
• Olympus Nasal & Sinus Endoscopes (K944072)
• KSEA Instrument Set for Endoscopic Surgery of Superfacial Veins and Fascia of the lower Extremities (K960903)
• Richard Wolf Instruments for Endoscopic Subfascial Discision of Perforating Veins - ESDP (K964258)

Submission Summary (Full Text)

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# 510 (k) SUMMA OLYMPUS SEPS SYSTEM

## SUBFASCIAL ENDOSCOPIC PERFORATING VEIN SURGERY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR, Section 807.92.

| Device Name: | Olympus SEPS System |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Subfascial Endoscopic Perforating Vein Surgery System |
| Classification Name: | Class II, 21 CFR 876.1500<br>Endoscope and Accessories. |
| Predicate Devices: | Olympus Subcutaneous Endoscopy System (K963184)<br>Endoscopic Plastic/Reconstructive and Aesthetic Surgery Endoscopes (K950076)<br>Endoscopic Plastic/Reconstructive and Aesthetic Surgery Hand Instruments (K950103)<br>Olympus Ultrathin Ureteroscope (K951855)<br>Olympus Nasal & Sinus Endoscopes (K944072)<br>KSEA Instrument Set for Endoscopic Surgery of Superfacial Veins and Fascia of the lower Extremities (K960903)<br>Richard Wolf Instruments for Endoscopic Subfascial Discision of Perforating Veins - ESDP (K964258) |
| Prepared & Submitted By:<br>(Contact Person) | Mr. Subhash Patel<br>Olympus America Inc.<br>Endoscope Division<br>Two Corporate Center Drive<br>Melville, New York 11747-3157<br>[phone] |
| Summary Preparation Date: | 08/27/97 |

#### Statement of Intended Use:

The Olympus SEPS System is designed for subcutaneous endoscopy -- more specifically, for endoscopically gaining access to vessels (arteries veins, ducts, nerves) in subcutaneous and subfascial surgical planes in the lower extremities for endoscopic observation, diagnosis, and treatment.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 21 1997

Mr. Subhash R. Patel ·Regulatory Affairs Associate Olympus America, Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157

Re: K973232

> Trade Name: Olympus Subfascial Endoscopic Perforating Vein Surgery (SEPS) System, its associated accessories and ancillary equipment ... .................... Regulatory Class: II Product Code: GCJ Dated: August 27, 1997 Received: August 28, 1997

Dear Mr. Patel:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Subhash R. Patel

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at ifs toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

to alefe

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### EXHIBIT # 2

## Indications for Use Statement

### 510(k) Number (if known): K 9732 32

Olympus Subfascial Endoscopic Perforating Vein Surgery (SEPS) System, Device Name: its associated accessories and ancillary equipment.

#### Indications for Use:

The Olympus SEPS . System is designed for subcutaneous endoscopy ------------------------------------------------------------------------------------------------------------endoscopically gaining access to vessels (arteries, veins, ducts, nerves) in subcutaneous and subfascial surgical planes in the lower extremities for endoscopic observation, diagnosis, and treatment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21CFR 801.109) | <div style="text-align:center;">X</div> |
|-----------------------------------------|-----------------------------------------|
|-----------------------------------------|-----------------------------------------|

OR

| Over-the Counter Use<br>(Optional Format 1-2-96) | |
|--------------------------------------------------|--|
|--------------------------------------------------|--|

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | K973232 |
| 510(k) Number | |

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