(161 days)
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No
The summary contains no mention of AI, ML, or related concepts, and the device description is a simple irrigation pump.
Yes
The device is described as an "Irrigation Pump" and is "indicated for irrigation of tissue," which is a direct medical intervention aimed at treating or managing a condition, thus making it a therapeutic device.
No
The device is indicated for irrigation of tissue, which is a treatment or procedural function, not a diagnostic one.
No
The device description explicitly states "Model 100 Irrigation Pump and Accessories," which indicates a physical hardware device (a pump) and associated components, not a software-only device.
Based on the provided information, the Conway Stuart Medical Model 100 Irrigation Pump and Accessories is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for irrigation of tissue." This describes a procedure performed directly on a patient's body (in vivo), not on samples taken from the body (in vitro).
- Device Description: The description is for an "Irrigation Pump and Accessories," which is a device used for delivering fluids during a medical procedure.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Reagents or test kits
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Conway Stuart Medical Model 100 Irrigation Pump is a therapeutic or procedural device used during surgery or other medical interventions.
N/A
Intended Use / Indications for Use
The Conway Stuart Medical Model 100 Irrigation Pump and Accessories is indicated for irrigation of tissue.
Product codes
GCJ, FPA
Device Description
Model 100 Irrigation Pump and Accessories
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing right, with flowing lines beneath them that resemble a river or stream.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 1999
Thomas C. Wehman, Ph.D. Regulatory and Quality Assurance Conway Stuart Medical, Inc. 735 Palomar Avenue Sunnyvale, California 94086
Re: K990724
Trade Name: Model 100 Irrigation Pump and Accessories Regulatory Class: II Product Code: GCJ and FPA Dated: June 4, 1999 Received: June 22, 1999
Dear Dr. Wehman:
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.
1
Page 2 - Thomas C. Wehman, Ph.D.
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
2
Conway Stuart Medical, Inc. Sunnyvale, California
K9907224
510(k) Premarket Notification Model 100 Irrigation Pump and Accessories
Indications for Use
TBD
510(k) Number (if known):
Device Name:
Indications for Use:
Contraindications for Use:
Model 100 Irrigation Pump and Accessories
The Conway Stuart Medical Model 100 Irrigation Pump and Accessories is indicated for irrigation of tissue.
The use of the CSM Model 100 Irrigation Pump and Accessories is contraindicated when, in the judgment of a medical practitioner, the use of irrigation would be contrary to the best interest of the patient.
(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 | |
| (Optional format 1-2-06) |
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990724
Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of Conway Stuart Medical, Inc.