(88 days)
The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalvestar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis.
The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.
The COMBICATH Catheter, is a radiopaque, double plugged, telescoping catheter designed to capture bronchoalveolar secretion samples in mechanically ventilated patients.
This 510(k) submission (K974642) is for a medical device called the COMBICATH Catheter, which is a physical device for sampling bronchoalveolar secretions, not an AI or software-driven diagnostic tool. Therefore, many of the requested categories related to AI performance metrics, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable.
The performance described is purely related to functional and safety testing of a physical device.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Results) |
|---|---|
| Functionality of the device under conditions similar to normal usage | Successful |
| Conformance to product specifications | Successful |
| Safety of the device | No issues raised regarding safety |
| Effectiveness of the device | No issues raised regarding effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a quantitative "sample size" in terms of number of catheters or patients for the functional and safety testing. It mentions "examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications." The data provenance is not explicitly stated but implies testing conducted by the manufacturer, Plastimed Laboratoire Pharmaceutique, as part of their product development and regulatory submission. It is likely prospective testing related to device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a physical device. Ground truth as typically understood for diagnostic AI (e.g., presence or absence of a disease) is not relevant here. The "ground truth" during testing would be whether the device physically functioned as intended and met specifications.
4. Adjudication Method for the Test Set
Not applicable. This is a physical device. Adjudication methods are typically used for evaluating human or AI interpretations of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is focused on the functional and safety performance of a physical sampling catheter, not on the interpretation of medical images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's testing was its functional performance and adherence to engineering specifications. This includes successful capture of bronchoalveolar secretion samples, material compatibility, and overall device integrity during simulated use, as well as meeting manufacturing and design specifications.
8. The Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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MAR 1 3 1998 510(k) Summary A. 510(K) SUMMARY Plastimed Laboratoire Pharmaceutique SUBMITTER: Mr. Mike McCormick CONTACT PERSON: Plastimed, LLC 212 3rd Avenue North, #446, Minneapolis, MN 55401 Phone: 612-317-4550 Fax: 612-317-4554 December 12, 1997 DATE PREPARED: COMBICATH Double Plugged Telescoping Catheter TRADE NAME: CLASSIFICATION NAME Bronchoscope (flexible or rigid) and Accessories and NUMBER: Class II, 21 CFR 874.4680 PRODUCT CODE: KTR The COMBICATH Catheter is substantially equivalent to the BAL PREDICATE DEVICE(S): Cath (K923487), manufactured by Ballard Medical. Other similar devices include the Rigid Suction Tip (K822255), the Argyle Taussig Culture Catheter (K791327), and the Argyle DeLee Suction Catheter (K820572), made by other manufacturers. DEVICE DESCRIPTION: The COMBICATH Catheter, is a radiopaque, double plugged, telescoping catheter designed to capture bronchoalveolar secretion samples in mechanically ventilated patients. INTENDED USE: The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalveolar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis. The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis. FUNCTIONAL & Functional and safety testing of the COMBICATH Catheter SAFETY TESTING: consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results of the examination and testing were successful, and did not raise any issues of safety and effectiveness of the device.
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CONCLUSION:
The COMBICATH Catheter is substantially equivalent to the BAL Cath (K923487), manufactured by Ballard Medical, based upon the devices' similarities in functional design, materials and indications for use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the border. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mike McCormick Plastimed L.L.C. 212 3rd Ave. North Suite 446 Minneapolis, MN 55401 Re:
K974642 Plastimed COMBICATH Catheter Dated: December 12, 1997 Received: December 15, 1997 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOO
Dear Mr. McCormick:
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 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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/odrh/dsmaldsmam.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
MAR 1 3 1998
Enclosure
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Indications for Use Page
The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalvestar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis.
The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K974642 |
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§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.