(56 days)
KGE
Not Found
No
The summary describes a mechanical device (hot biopsy forceps) used for simultaneous biopsy and coagulation, with no mention of AI/ML, image processing, or data-driven performance metrics.
Yes
Hot biopsy forceps are used for simultaneous biopsy and coagulation of polyps, which are medical procedures aimed at treating or alleviating a disease or condition (polyps).
No
The device is described as "hot biopsy forceps" intended for "simultaneous biopsy and coagulation of diminutive polyps," rather than for diagnosing a condition. Its function is to perform a procedure (biopsy and coagulation), not to identify a disease state.
No
The device is described as "hot biopsy forceps," which are physical instruments used for biopsy and coagulation. The description of its intended use in conjunction with an electrocautery unit further indicates a hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "simultaneous biopsy and coagulation of diminutive polyps" in conjunction with an electrocautery unit. This describes a procedure performed on the patient's tissue in vivo (within the living body), not a test performed on a sample in vitro (outside the living body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Providing diagnostic information based on the analysis of these samples
- Using reagents or assays
The device is a surgical instrument used for a therapeutic and diagnostic procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The LSVP International, Inc. Hot Biopsy Forceps are intended for simultaneous biopsy and coagulation of diminutive polyps. Hot biopsy forceps are intended for use in conjunction with an electrocautery unit.
The primary indication for hot biopsy forceps is simultaneous biopsy and coagulation of diminutive polyps. Hot biopsy forceps are intended for use in conjunction with an electrocautery unit.
Product codes
KGE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reusable Hot Biopsy Forceps manufactured by Olympus, by Microvasive Corp., by Fujinon, Inc., and by Mill-Rose Labs.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
K971204
171 3
Summary of Safety and Effectiveness
MAY 27 1997
LSVP International Hot Biopsy Forceps
| Device Name: | LSVP International Hot Biopsy Forceps |
|---|---|
| Common/Usual Name: | Hot Biopsy Forceps |
| Classification Name: | Gastroenterology urology biopsy instruments (Class II, Tier 2) |
| Predicate Devices: | Reusable Hot Biopsy Forceps manufactured by Olympus, by |
| Microvasive Corp., by Fujinon, Inc., and by Mill-Rose Labs. | |
| Submitted by: | |
| (contact person) | Ms. Sophia Pesotchinsky |
| LSVP International, Inc. | |
| 12755 Alto Verde Lane | |
| Los Altos Hills, | |
| Telephone: (415) 917-8100 | |
| FAX: (415) 948-7822 | |
| Summary Preparation Date: | March 27, 1997 |
| Statement of Intended Use: | The LSVP International, Inc. Hot Biopsy Forceps are intended |
| for simultaneous biopsy and coagulation of diminutive polyps. | |
| Hot biopsy forceps are intended for use in conjunction with an | |
| electrocautery unit. | |
| Comparison to Predicate Devices: | The LSVP International, Inc., Reusable Hot Biopsy Forceps are |
similar in design, function, and intended use to the currently marketed reusable Olympus hot biopsy forceps.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread and its head turned to the right. The eagle is composed of three curved lines, and it appears to be in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1997
Ms. Sophia Pesotchinsky Vice President, Regulatory Affairs LSVP International, Inc. 12755 Alto Verde Lane Los Altos Hills, California 94022 Re: K971204 LSVP International Hot Biopsy Forceps Dated: April 14, 1997 Received: April 18, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 KGE
Dear Ms. Pesotchinsky:
We have reviewed your Section 510(k) notification of intent to market the device 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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) 594-4616. 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.
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
2
2. Indication for use statement
510(k) number K971204
Device name: LSVP International Hot Biopsy Forceps
INDICATION FOR USE:
The primary indication for hot biopsy forceps is simultaneous biopsy and coagulation of diminutive polyps.
Hot biopsy forceps are intended for use in conjunction with an electrocautery unit.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1204
Robert R. Selling/
(Division Sign-Off)
Division of Reproductive, Accioninal, ENT, and Radiological Devices
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_
(Optional Format 1-2-96)