(65 days)
Not Found
None
No
The summary describes a mechanical biopsy forceps and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device, "Reusable Biopsy Forceps," is used for obtaining tissue samples and retrieving foreign bodies, which are diagnostic and interventional procedures, not therapeutic.
No
The device is described as reusable biopsy forceps used for obtaining tissue samples and retrieving foreign bodies and stones. Its function is to collect specimens or remove obstructions, not to diagnose conditions.
No
The device description clearly states "Reusable Biopsy Forceps," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to obtain tissue samples, retrieve foreign bodies and stones from the body (GJ and Urinary tracts, lungs). This is a procedure performed on the patient, not a test performed on a sample outside the body to diagnose a condition.
- Device Description: It's described as "Reusable Biopsy Forceps," which are instruments used for physical manipulation within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory testing of biological specimens.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for sample collection and retrieval.
N/A
Intended Use / Indications for Use
The TeleMed Systems, Inc. Reusable Biopsy Forceps are indicated for use in obtaining endoscopically tissue samples, retrieval of foreign bodies and stones from the GJ and Urinary tracts and the lungs
Product codes
78 KNW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GJ and Urinary tracts and the lungs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized representation of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 21 1998
Samual D. Wade RAC Vice President - Operations TeleMed Systems, Inc. 19 Brigham Street, Unit 1 Marlborough, MA 01752
Re: K974312
TeleMed Systems Reusable Biopsy Forceps Dated: November 11, 1997 Received: November 17, 1997 Regulatory Class: II 21 CFR 876.1075/Procode: 78 KNW
Dear Mr. Wade:
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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 vou might have under sections 531 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 yitro 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/cdrh/dsmamain.html".
Sincerely yours.
h.J.liau Yi
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
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K 97431V
Indication for Use:
The TeleMed Systems, Inc. Reusable Biopsy Forceps are indicated for use in obtaining endoscopically tissue samples, retrieval of foreign bodies and stones from the GJ and Urinary tracts and the lungs
Robert R Salling/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices 974712 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use.