(47 days)
Laparoscopes are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, gastric bypass, laparoscopic Nissen and examination of the abdominal cavity, appendix, gallbladder and liver.
Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of their patient population.
The Stryker Bariatric Laparoscope is a reusable rigid endoscopc, packaged in the not-sterile state.
The provided text describes a 510(k) submission for a medical device, the Stryker Bariatric Laparoscope, which is a design modification of an existing laparoscope. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device rather than defining new, specific performance acceptance criteria for the modified device in isolation. The acceptance criteria essentially revolve around showing that the modified device performs equivalently to the predicate device in key aspects and introduces no new safety or effectiveness concerns.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Sterilizability (10^-6 sterility assurance level) | "demonstrated to be sterilizable with a sterility assurance level (SAL) of 10^-6 under a variety of recommended sterility assurance cycles at health care facilities, including: ethylene oxide, steam autoclave, Sterrad and Steris." |
| Biocompatibility (per ISO 10993 and CDRH G95-1 guidance) | "constructed of materials which are tested for biocompatibility per ISO 10993 and CDRH G95-1 guidance; these material are non-toxic and durable for their intended purposes." |
| Electrical Safety (conformance to IEC 601-2-18) | "conforms to the electrical safety requirements of IEC 601-2-18 as a type BF or type CF applied part of medical electrical equipment." |
| Optical Performance (Equivalent to Predicate) | "The Stryker Bariatric Laparoscope has been evaluated to ensure equivalent optical performance to the predicate device." (No specific metrics provided, but implies testing was done to confirm non-inferiority or equivalence) |
| Mechanical Strength and Rigidity (Equivalent to Predicate) | "The Stryker Bariatric Laparoscope has been evaluated to ensure equivalent mechanical strength and rigidity under loads normally expected in laparoscopic surgery." (No specific metrics provided, but implies testing was done to confirm non-inferiority or equivalence under surgical loads) |
| No new issues compared to predicate device or uses | "The Stryker Bariatric Laparoscope does not introduce new issues when compared to its predicate device or uses. Therefore the Stryker Bariatric Laparoscope is considered to be substantially equivalent to its predicate device and uses." (This is a conclusion drawn from the cumulative evaluation of the above criteria.) |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify a sample size for a test set in the traditional sense of clinical or performance testing with a 'test set' of subjects or cases. The evaluation appears to be primarily focused on bench testing and engineering assessments of the device's technical specifications and material properties against established standards or in comparison to the predicate device.
- Data Provenance: The nature of the tests (sterilization cycles, biocompatibility, electrical safety, optical performance, mechanical strength) suggests that the data would be derived from laboratory testing and engineering analyses performed by the manufacturer, Stryker Endoscopy. It is retrospective in the sense that the testing was performed on the manufactured device models to support the submission (i.e., not a prospective clinical trial). There is no mention of country of origin of the data beyond the manufacturer's location in Santa Clara, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable in the traditional sense. For a 510(k) submission showing substantial equivalence for a device like a laparoscope, "ground truth" isn't established by expert consensus on clinical cases. Instead, the "ground truth" or reference points are:
- Established international and national standards (e.g., ISO 10993, IEC 601-2-18).
- The performance characteristics of the predicate device (K910132).
- General understanding of expected performance for endoscopes in laparoscopic surgery.
- The individuals who conducted and interpreted these engineering and material tests would be qualified engineers, material scientists, and regulatory specialists employed by Stryker Endoscopy or their contracted testing facilities. Their specific number and qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set:
- Not Applicable. Since there isn't a "test set" of patient cases requiring expert review or a "ground truth" established by multiple experts in a clinical context, an adjudication method like 2+1 or 3+1 is not relevant to the information provided. The "adjudication" for this submission would be the FDA's regulatory review process.
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:
- No MRMC study was done. This device is a surgical instrument (laparoscope), not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study evaluating human reader performance with or without AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a rigid endoscope, which is a hardware instrument. It does not contain an algorithm or AI component to be tested in a standalone fashion.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As explained in point 3, the "ground truth" is not patient-specific clinical ground truth. Instead, it relies on:
- Adherence to recognized standards: ISO 10993 for biocompatibility, IEC 601-2-18 for electrical safety.
- Comparison to predicate device specifications: For optical performance, mechanical strength, and rigidity.
- Demonstrated performance against validated test methods: For sterilization efficacy.
8. The sample size for the training set:
- Not Applicable. This device development did not involve a "training set" in the context of machine learning or AI. It's a hardware modification.
9. How the ground truth for the training set was established:
- Not Applicable. As explained in point 8, there was no training set for this device.
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Image /page/0/Picture/0 description: The image shows the Stryker Endoscopy logo. The word "Stryker" is in a bold, sans-serif font, with the "r" slightly raised. To the right of "Stryker" is the word "ENDOSCOPY" in a smaller, sans-serif font, inside of a black rectangle.
2590 Walsh Avenue Santa Clara, CA 95051
OCT 27 1999
(408) 567-9 1-800-435-0111
Attachment 6
510 (k) Summary Safety and Efficacy
· Device Name
Current Classification Name(s): Endoscope 21 CFR 876.1500 Class II Common and Usual Name: Laparoscope Proprietary Name: Stryker Bariatric Laparoscope
Device Sponsor:
Stryker Endoscopy 2590 Walsh Ave. Santa Clara, CA 95051
This summary of 510(k) safety and effectiveness is submitted in accordance with requirements of SMDA:1990.
equirements of SMDATI990.
The Stryker Bariatric Laparoscope is a design modification been Laparoscope, K910132 of 2/21/91. The useful length of the device has been Laparoscope, R910132 Of 2721731. The aborar 2019.
increased to a length appropriate for laparoscopic surgery on morbidly obese patients.
The Stryker Bariatric Laparoscope is a reusable rigid endoscopc, packaged in the not-sterile state.
The Stryker Bariatric Laparoscope is cleaned and sterilized by the user prior of the Scryker Darlations and our demonstrated to be sterilizable with a prior to arr uses. The doviets) of 10-6 under a variety of recommended sterility assurance rever (brid) or io health care facilities, including: steritation mosteam autoclave, Sterrad and Steris.
me oxide, Sceam adcociate, Scear is constructed of materials which are tested for biocompatibility per ISO 10993 and CDRH G95-1 guidance; these cested for broomparative and durable for their intended purposes.
The Stryker Bariatric Laparoscope conforms to the electrical safety requirements of IEC 601-2-18 as a type BF or type CF applied part of medical electrical equipment.
rcar equipment.
The Stryker Bariatric Laparoscope has been evaluated to ensure equivalent optical performance to the predicate device.
The Stryker Bariatric Laparoscope has been evaluated to ensure equivalent mechanical strength and rigidity under loads normally expected in laparoscopic surgery.
The Stryker Bariatric Laparoscope does not introduce new issues when compared to its predicate device or uses. Therefore the Stryker Bariatric Laparoscope is considered to be substantially equivalent to its predicate device and uses.
summr
R. H. Dahla Associate Project Engineer Stryker Endoscopy
9-7-99
Date
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Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on a single line.
DEPARTMENT OF HEALTH & HUMAN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 1999
Mr. Robert H. Dahla Associate Project Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051
K993045 Re: Trade Name: Stryker Bariatric Laparoscope Regulatory Class: II Product Code: GCJ Dated: September 10, 1999 Received: September 10, 1999
Dear Mr. Dahla:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 device in the Federal Register. Please note: this response to your premarket notification submission 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. Robert H. Dahla
This letter will allow you to begin marketing your device as described in your 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 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 device, 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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Attachment 2
Indications for Use Statement
510(k) Number:
Stryker Bariatric Laparoscope Device Name:
Indications for Use:
Laparoscopes are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, gastric bypass, laparoscopic Nissen and examination of the abdominal cavity, appendix, gallbladder and liver.
Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of their patient population.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | ✓ | OR | Over-the-Counter Use |
|---|---|---|---|
| ------------------------------------------ | --------------------------------------------------- | ---- | ----------------------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K993045 |
§ 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.