(17 days)
The Manan Techna-Cut biopsy needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
The Manan Techna-Cut biopsy needle is a cutting biopsy needle based upon the Menghini cutting tip geometry. A syringe is included with the syringe used is a locking syringe. The Manan Techna-Cut biopey needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
The provided text does not contain detailed information about the acceptance criteria or a study that specifically proves the device meets those criteria for the Manan™ Techna-Cut Biopsy Needle. The 510(k) summary focuses on establishing substantial equivalence to a predicate device (Manan Medical Products Techna-Cut Biopsy Needle, K943651).
The information provided is primarily for regulatory clearance based on substantial equivalence, which often relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than explicit performance acceptance criteria from a specific study.
Therefore, many of the requested fields cannot be filled based on the given document.
Here's an attempt to extract and infer information, acknowledging the limitations of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated in the document. Substantial equivalence for this type of device typically implies that its performance (e.g., ability to obtain biopsy material, safety profile) is comparable to the predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Substantial Equivalence) |
|---|---|
| Ability to obtain biopsy material from specified tissues | Comparable to predicate device Manan Techna-Cut Biopsy Needle (K943651) |
| Safety profile (e.g., risk of complications) | Comparable to predicate device Manan Techna-Cut Biopsy Needle (K943651) |
| Cutting tip geometry and function | Based on Menghini cutting tip geometry, comparable to predicate device |
2. Sample size used for the test set and the data provenance
Not specified. The 510(k) summary does not describe a new clinical or performance study with a distinct test set. Substantial equivalence is often based on design similarities, materials, and intended use as compared to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no specific test set requiring expert ground truth is described in the provided document.
4. Adjudication method for the test set
Not applicable, as no specific test set requiring adjudication is described in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a biopsy needle, not an AI-assisted diagnostic tool, and the document does not mention any MRMC studies or AI involvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a biopsy needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly stated. For a reusable surgical instrument like a biopsy needle cleared via 510(k), ground truth often relates to successful tissue acquisition and histological analysis to confirm the presence of viable tissue, and clinical outcomes for safety. The document implies that the device's ability to obtain biopsy material from specified tissues is central, suggesting that histological confirmation would be the ultimate ground truth in any performance evaluation.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
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MD
4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
JAN - 8 1998
510(k) SUMMARY
| APPLICANT: | Medical Device Technologies, Inc.4445-310 SW 35th TerraceGainesville, FL 32608 | |
|---|---|---|
| CONTACT: | Karl SwartzQuality Assurance Manager | |
| TELEPHONE: | (352)338-0440fax (352)338-0662 | |
| TRADE NAMES: | Manan™ Techna-Cut Biopsy Needle | |
| COMMON NAME: | Biopsy needle | |
| CLASSIFICATION NAME: | §878.4800-Manual surgical instrument for generaluse; disposable aspiration and injection needle. | |
| SUBSTANTIAL EQUIVALENCE: | ||
| Company Name | Product Name | 510(k) No. |
| Manan Medical Products | Techna-Cut Biopsy Needle | K943651 |
DESCRIPTION OF DEVICE:
The Manan Techna-Cut biopsy needle is a cutting biopsy needle based upon the Menghini cutting tip geometry. A syringe is included with the syringe used is a locking syringe. The Manan Techna-Cut biopey needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, with flowing lines suggesting movement or energy. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 1998
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainsville, Florida 32608
Re: K974766 Trade Name: Manan™ Techna-Cut Biopsy Needle Regulatory Class: II Product Code: KNW Dated: December 18, 1997 Received: December 22, 1997
Dear Mr. Swartz:
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 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 current Good Manufacturing Practice requirements , as set forth in the Onality 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 you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Swartz
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 vour 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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MD
4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Manan™M
Indications for Use:
The Manan Techna-Cut biopsy needle is intended for use in obtaining biopsy material from tissues such as the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office | Device Evaluation (ODE) |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | IL974766 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1 -- -
§ 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.