(80 days)
The DAUM Bone Biopsy Set is intended for the biopsy of bone tissue. The DAUM Bone Biopsy Set is also a low-artifact-instrument designed to be used in the MRI for the above purpose.
The DAUM Bone Biopsy Set consists of a working tube, stylet, power drill drive, manual drill and an ejector drift. The drill is supplied as a disposable unit. All of the other components of the set are supplied as reusable products.
The provided text describes a 510(k) summary for the DAUM Bone Biopsy Set. It focuses on establishing substantial equivalence to a predicate device and notes performance data related to MR Safety. However, it does not contain the detailed clinical study information typically found when a device's diagnostic or therapeutic efficacy is being evaluated against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled from the given text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: For the biopsy of bone tissue. | The DAUM Bone Biopsy Set is specified as being "intended for the biopsy of bone tissue." |
| Technological Characteristics: Substantially equivalent in design, material, intended use and function to predicate devices. | The document states: "Both the DAUM Biopsy Needle and the Bone Biopsy Set Device are substantially equivalent in design, material, intended Characteristics and Comparison Predicate use and function." |
| MR Safety: Acceptable for patient use in a 0.2T static magnetic field. | The DAUM Bone Biopsy Set "has been tested for MR Safety in a 0.2T static magnetic field and was found to be acceptable for patient use in this environment." |
| Low-artifact-instrument for MRI: Designed to be used in MRI for bone biopsy with low artifacts. | The device is "a low-artifact-instrument designed to be used in the MRI for the above purpose." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document only mentions "Performance Data: The DAUM Bone Biopsy Set has been tested for MR Safety in a 0.2T static magnetic field." It does not specify the sample size of any test set (e.g., number of patients, number of devices tested), nor its provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not available in the provided text. The testing described relates to MR safety, not a diagnostic or efficacy study requiring expert assessment of ground truth in the usual sense (e.g., disease presence). No experts are mentioned in relation to establishing ground truth for the MR Safety test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available in the provided text. This type of adjudication is typically for diagnostic studies. The MR safety test described would not involve such a method.
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
- No, an MRMC comparative effectiveness study was not done. This device is a biopsy set, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (bone biopsy set), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the MR Safety testing, the ground truth would have been established by engineering standards and measurement criteria for magnetic field interactions, heating, and artifact generation, not clinical outcomes or expert consensus on diagnosis. The method for determining "acceptable for patient use" in an MR environment would be based on established safety limits and methods for testing metallic implants/devices in MRI.
8. The sample size for the training set
- Not applicable/Not available in the provided text. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML device.
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JUN 2 9 1998
510(K) SUMMARY
DAUM BONE BIOPSY SET
| Submitter Name: | DAUM Corporation |
|---|---|
| ----------------- | ------------------ |
- 1450 South Rolling Road Address: Submitter Baltimore, Maryland 21227
- Person: Pete Osborn Contact
- 410-455-5786 Phone Number:
- Facsimile Number: 410-455-5787
- Prepared: 3 April 1998 Date
- Trade Name: DAUM Bone Biopsy Set Device
- Name: Bone Biopsy Needle Device Common
- Name: Classification Set, Biopsy Needle
- DAUM Biopsy Needle Predicate Devices:
The DAUM Bone Biopsy Set consists of a working tube, Device Description: stylet, power drill drive, manual drill and an ejector drift. The drill is supplied as a disposable unit. All of the other components of the set are supplied as reusable products.
- The DAUM Bone Biopsy Set is intended for the biopsy of Intended Use: bone tissue.
Technological Both the DAUM Biopsy Needle and the Bone Biopsy Set Device are substantially equivalent in design, material, intended Characteristics and Comparison Predicate use and function. to Devices(s):
The DAUM Bone Biopsy Set has been tested for MR Safety Performance Data: in a 0.2T static magnetic field and was found to be acceptable for patient use in this environment.
- Conclusion: The DAUM Bone Biopsy Set which is intended for the biopsy of bone tissue is also a low-artifact-instrument designed to be used in the MRI for the above purpose.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 1998
· DAUM Corporation c/ o Mr. Gary J. Sfeir, RAC Greatbatch Scientific 9645 Wehrle Drive Clarence, New York 14031
Re: K981320 Trade Name: DAUM Bone Biopsy Set Regulatory Class: II Product Code: KNW Dated: April 7, 1998 Received: April 10, 1998
Dear Mr. Sfeir:
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 requirement, as set forth in the Quality 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 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.
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Page 2 - Mr. Gary J. Sfeir
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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510(k)Number(if known):
Device Name: DAUM Bone Biopsy Set
Classification Panel:
Indications for Use: K981320
The DAUM Bone Biopsy Set is intended for the biopsy of bone tissue. The DAUM Bone Biopsy Set is also a low-artifact-instrument designed to be used in the MRI for the above purpose.
Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
tcollez
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
or
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.