(47 days)
No
The summary describes a rigid endoscope and does not mention any AI or ML capabilities.
No
Explanation: The device is a laparoscope used in diagnostic and therapeutic procedures, but it is an instrument that enables the procedure, not a therapeutic device itself. Its function is primarily visualization and instrument delivery rather than directly providing a therapeutic effect.
Yes
The "Intended Use / Indications for Use" section explicitly states that laparoscopes are "intended to be used by surgeons in diagnostic and therapeutic procedures" and lists "examination of the abdominal cavity, appendix, gallbladder and liver" as a use.
No
The device description explicitly states it is a "reusable rigid endoscope," which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Stryker Bariatric Laparoscope is a reusable rigid endoscope used by surgeons in diagnostic and therapeutic procedures within the abdominal cavity. It is inserted into the body through small skin punctures to visualize internal organs and facilitate surgical procedures.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to provide visual access and aid in surgical interventions.
Therefore, the Stryker Bariatric Laparoscope is a surgical instrument used for visualization and manipulation within the body, not a device that performs tests on biological samples outside the body.
N/A
Intended Use / 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.
Product codes
GCJ
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons / 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)
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 has been 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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.
2
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
3
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 |