(16 days)
The Mananths Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
These devices are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
The provided document is a 510(k) summary for Medical Device Technologies, Inc.'s Manan™ Soft Tissue Biopsy Needles. This document establishes the substantial equivalence of the new needles to previously marketed predicate devices.
This document describes a medical device (biopsy needles), not an AI/ML powered device. Therefore, the concepts of acceptance criteria for AI algorithm performance, sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable here.
The primary "acceptance criterion" for a traditional medical device in a 510(k) submission is demonstrating substantial equivalence to a previously legally marketed device (predicate device).
Here's how the document addresses the "acceptance criteria" and the "study" that proves the device meets them, interpreted for a non-AI medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (for 510(k) submission) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Substantial Equivalence to a Predicate Device (in terms of indications for use, technological characteristics, and safety/effectiveness) | The Manan™ Soft Tissue Biopsy Needles are substantially equivalent to the predicate devices listed (Medical Device Technologies, Inc.'s Manual Biopsy Needles K944837 and various Manan Medical Products biopsy needles: Franseen Needle K851831, Greene Needle K851835, Westcott Needle K851837, Chiba Needle K851838, Trocar Needle K852426, Spinal Needle K852427, Turner Needle K873208). |
| Intended Use (Percutaneous soft tissue biopsies under guidance) | The device's intended use is identical to, or within the scope of, the predicate devices: for percutaneous soft tissue biopsies (pleura cavity, abdominal cavity, etc.), inserted by a qualified physician under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy) to retain a tissue specimen. |
| Technological Characteristics (as implies by substantial equivalence) | Implied to be sufficiently similar in design, materials, and operating principle to the predicate devices such that no new questions of safety or effectiveness are raised. The description states "These devices are intended to be used... and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle," which describes the fundamental operation of the predicate devices. |
| Safety and Effectiveness (as implies by substantial equivalence) | Implied to be as safe and effective as the predicate devices, as no new safety or effectiveness concerns were identified during the review. The FDA's decision to allow marketing (K980122) confirms this. |
2. Sample size used for the test set and the data provenance
- Not Applicable. For a 510(k) substantial equivalence submission for a traditional medical device like a biopsy needle, there isn't a "test set" in the sense of a dataset to evaluate an algorithm's performance. The "testing" often refers to bench testing (e.g., material strength, needle sharpness, tissue capture effectiveness) and potentially pre-clinical in-vivo models. These details are typically in supporting documentation not included in this summary. There is no mention of human subject data, retrospective or prospective studies in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for a medical device's performance would be established through established engineering standards, material science, and clinical practice, rather than expert annotation of a dataset.
4. Adjudication method for the test set
- Not Applicable. As there is no "test set" for algorithm evaluation, no adjudication method is relevant.
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 is specific to AI/ML devices and human-in-the-loop studies. This document concerns a basic surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is specific to AI/ML algorithms.
7. The type of ground truth used
- Not Applicable (in the AI/ML sense). For a traditional medical device, the "ground truth" for its function and safety is based on scientific principles, engineering design, manufacturing quality, and comparison to existing, legally marketed devices with a known safety and efficacy profile.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this type of medical device's submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
In summary: The provided document is purely a 510(k) summary for a traditional medical device (biopsy needles) seeking regulatory clearance based on substantial equivalence. It does not involve any artificial intelligence or machine learning components, and therefore, the detailed questions about AI acceptance criteria, data sets, expert ground truth, and studies are not applicable to this submission. The "study" here is the comparative analysis demonstrating substantial equivalence to predicate devices, which the FDA affirmed.
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JAN 30 1998
ainesville, Florida 3 TEL: 352/338-0440 FAX: 352/338-0662
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™ Soft Tissue Biopsy Needles |
| COMMON NAME: | Manual biopsy needles for soft tissue biopsies |
| SIFICATION NAME: | Needle, Biopsy, Cardiovascular, No. 79DWO |
SUBSTANTIAL EQUIVALENCE:
CLASS
| Company Name | Product Name | 510(k) No |
|---|---|---|
| Medical Device Technologies, Inc. | Manual Biopsy Needles | K944837 |
| Manan Medical Products | Franseen Needle | K851831 |
| Manan Medical Products | Greene Needle | K851835 |
| Manan Medical Products | Westcott Needle | K851837 |
| Manan Medical Products | Chiba Needle | K851838 |
| Manan Medical Products | Trocar Needle | K852426 |
| Manan Medical Products | Spinal Needle | K852427 |
| Manan Medical Products | Turner Needle | K873208 |
DESCRIPTION OF DEVICE:
These devices are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Mr. Karl Swartz Ouality Assurance Manager Medical Device Technologies, Incorporated 4445-310 S.W. 35th Terrace Gainesville, Florida 32608
Re: K980122
Trade Name: Manan™ Soft Tissue Biopsy Needles Regulatory Class: II Product Code: KNW Dated: December 31, 1997 Received: January 14, 1998
Dear Mr. Swartz:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 Ouality 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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.
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Page 2 - Mr. Swartz
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
to sollyz
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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445-310 S.W. 35th Te Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page 1 of 1
510(k) Number (if known): __ K980122
Device Name: Manan™ Soft Tissue Biopsy Needles
Indications for Use:
The Mananths Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K980122 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| --------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
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§ 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.