(34 days)
The primary indication for use of biopsy forceps is endoscopic tissue collection for histologic examination in GI/Urology, Bronchoscopy, Nasopharingoscopy, Esophagoscopy and Hysteroscopy. Non-electric biopsy forceps are not intended for use in conjunction with an electrocautery unit.
Not Found
The provided document is a 510(k) premarket notification for the LSVP International Biopsy Forceps. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through clinical studies with specific acceptance criteria and detailed performance reports.
Therefore, the document does not contain the information requested in points 1 through 9 regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment.
Here's why and what the document does provide:
- Nature of the Submission: A 510(k) submission typically relies on non-clinical performance testing (e.g., mechanical testing, biocompatibility) and a comparison to a predicate device. It generally does not require or include extensive clinical studies with human subjects that would involve establishing specific acceptance criteria for diagnostic performance (like sensitivity/specificity), ground truth, or MRMC studies.
- Focus: The focus of this document is to establish that the LSVP Biopsy Forceps are "substantially equivalent" in design, function, and intended use to existing predicate devices (Reusable Biopsy Forceps manufactured by Olympus, Portlyn Corp., and American Endoscopy, Corp.).
- Intended Use: The device is intended "specifically to collect tissue endoscopically for histologic examination." This is a tissue collection tool, not a diagnostic algorithm that would have performance metrics like sensitivity, specificity, or reader improvement.
In summary, none of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, or ground truth establishment for a diagnostic performance study is present because this is a 510(k) submission for a medical device (biopsy forceps) and not a diagnostic algorithm or a software as a medical device (SaMD) that would typically generate such data.
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Summary of Safety and Effectiveness
LSVP International Biopsy Forceps
| Device Name: | LSVP International Biopsy Forceps |
|---|---|
| Common/Usual Name: | Biopsy Forceps |
| Classification Name: | Endoscopic biopsy instruments (Class II, Tier 1) |
| Predicate Devices: | Reusable Biopsy Forceps manufactured by Olympus, by PortlynCorp., by American Endoscopy, Corp. |
| Submitted by: | Mr. Leon Pesotchinsky |
| (contact person) | LSVP International, Inc.12755 Alto Verde LaneLos Altos Hills,Telephone: (650) 917-8100FAX: (650) 948-7822 |
| Summary Preparation Date: | August 19, 1998 |
| Statement of Intended Use: | The LSVP International, Inc. Biopsy Forceps are intendedspecifically to collect tissue endoscopically for histologicexamination. |
| Comparison to Predicate Devices: | The LSVP International, Inc., Biopsy Forceps aresimilar in design, function, and intended use to the currentlymarketed reusable Olympus biopsy forceps. |
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Image /page/1/Picture/1 description: The image shows a partial view of a document with some text and a graphic. The text includes the abbreviation "SEP" followed by the number "29". There is also a partial graphic on the left side of the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Leon Pesotchinsky President LSVP International, Inc. 12755 Alto Verde Lane Los Altos Hills. CA 94022 Re:
LSVP Biopsy Forceps Dated: August 19, 1998 Received: August 26, 1998 Regulatory class: II 21 CFR 874.4480/Procode: 77 EOQ
Dear Mr. Pesotchinsky:
We have reviewed your Section 510K) 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 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 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 myght 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/cdch/dsmam.n.html".
Sincerely yours,
Kilian Yih~
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
Enclosure
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A. Indication for Usc Statement
Device name: LSVP International Biopsy Forceps
INDICATION FOR USE:
The primary indication for use of biopsy forceps is endoscopic tissue collection for histologic examination in GI/Urology, Bronchoscopy, Nasopharingoscopy, Esophagoscopy and Hysteroscopy. Non-electric biopsy forceps are not 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)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic
510(k) Number K982983
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. a.r. as tal l
§ 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.