(85 days)
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.
Not Found
The provided text describes a 510(k) submission for the Olympus SEPS System but does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) summary, specifically the FDA's clearance letter and the manufacturer's statement of intended use. It focuses on the regulatory classification and the determination of substantial equivalence to predicate devices, rather than performance or efficacy studies.
Therefore, I cannot provide the requested information based on the given text.
If this were a typical device submission with performance data, the following would be the expected information:
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Table of Acceptance Criteria and Reported Device Performance: This would typically be a table comparing pre-defined thresholds for performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device; or specific functional requirements for a surgical device) against the results achieved in a study.
- Example for an imaging device:
Metric Acceptance Criteria Reported Performance Sensitivity > 90% 92.5% Specificity > 80% 85.1% Accuracy > 85% 88.0%
- Example for an imaging device:
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Sample size used for the test set and the data provenance: This would state how many cases were used to evaluate the device's performance and where that data came from (e.g., 200 patient cases from a multi-center retrospective study in the USA and Europe).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This would detail the number of clinicians who provided the reference standard for the test data and their relevant experience (e.g., 3 board-certified radiologists, each with 10+ years of experience in thoracic imaging).
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Adjudication method for the test set: How disagreements among experts were resolved (e.g., 2+1 means two experts agree, or a third expert adjudicates if the first two disagree; 3+1 means three experts agree, or a fourth adjudicates).
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Yes/No, and if yes, the effect size for human readers with/without AI assistance.
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If a standalone (algorithm only without human-in-the-loop performance) was done: Yes/No, and the results if applicable.
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The type of ground truth used: What the reference standard was based on (e.g., histopathology, clinical follow-up, consensus of multiple experts, outcome data).
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The sample size for the training set: How many cases/data points were used to train the algorithm (for AI/ML devices).
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How the ground truth for the training set was established: Similar to point 7, but specifically for the data used to teach the algorithm.
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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 876.1500Endoscope and Accessories. |
| 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) |
| Prepared & Submitted By:(Contact Person) | Mr. Subhash PatelOlympus America Inc.Endoscope DivisionTwo Corporate Center DriveMelville, New York 11747-3157(516) 844-5481 |
| 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(per 21CFR 801.109) | X |
|---|---|
| ----------------------------------------- | ----------------------------------------- |
OR
| Over-the Counter Use(Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | K973232 |
| 510(k) Number |
4
§ 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.