(34 days)
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No
The summary describes a mechanical biopsy forceps and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as "biopsy forceps" intended for tissue collection for histologic examination, which is a diagnostic procedure, not a therapeutic one.
No
Explanation: The device, biopsy forceps, is used for tissue collection for histologic examination. While the examination may lead to a diagnosis, the device itself is a tool for specimen acquisition, not for performing the diagnostic analysis.
No
The device is described as "biopsy forceps," which are physical instruments used for tissue collection. The description of intended use and predicate devices further confirms it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endoscopic tissue collection for histologic examination". This describes a tool used to obtain a sample from the body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The test itself is performed outside the body.
- Device Function: The device described is a biopsy forceps, which is a tool for collecting the sample, not for performing the diagnostic test on the sample. The histologic examination (the diagnostic test) is performed after the tissue is collected using the forceps.
Therefore, the biopsy forceps is a medical device used in the process of obtaining a sample for an IVD test, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The LSVP International, Inc. Biopsy Forceps are intended specifically to collect tissue endoscopically for histologic examination.
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.
Product codes
77 EOQ
Device Description
The LSVP International, Inc., Biopsy Forceps are similar in design, function, and intended use to the currently marketed reusable Olympus biopsy forceps.
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
GI/Urology, Bronchoscopy, Nasopharingoscopy, Esophagoscopy and Hysteroscopy (for tissue collection via endoscopy).
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reusable Biopsy Forceps manufactured by Olympus, by Portlyn Corp., by American Endoscopy, Corp.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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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 Portlyn |
| Corp., by American Endoscopy, Corp. | |
| Submitted by: | Mr. Leon Pesotchinsky |
| (contact person) | LSVP International, Inc. |
| 12755 Alto Verde Lane | |
| Los Altos Hills, | |
| Telephone: (650) 917-8100 | |
| FAX: (650) 948-7822 | |
| Summary Preparation Date: | August 19, 1998 |
| Statement of Intended Use: | The LSVP International, Inc. Biopsy Forceps are intended |
| specifically to collect tissue endoscopically for histologic | |
| examination. | |
| Comparison to Predicate Devices: | The LSVP International, Inc., Biopsy Forceps are |
| similar in design, function, and intended use to the currently | |
| marketed 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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