(69 days)
The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.
The device is a hand-held battery powered device that penetrates the bone and allows aspiration through a hole in the bit for bone marrow harvest. The device is made from medical grade components and sold as a disposable procedure kit and a reusable motor unit.
This document is a 510(k) summary for the BioAccess Marrow Harvest System, submitted in 1997. It describes a medical device and its substantial equivalence to previously marketed devices. The document does not contain information about acceptance criteria or a study proving a device meets acceptance criteria, as it pertains to a physical medical device (a marrow harvest system) and not an AI/ML powered device.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically associated with AI/ML device submissions, which are much more recent than a 1997 510(k) for a physical surgical instrument.
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510(k) Summary
JUN - 3 1997
Information as required by 21 CFR 807.92 is provided:
| (1) | Submitter Information | BioAccess, Inc. |
|---|---|---|
| 4000 Hudson Street | ||
| Baltimore, MD 21224 | ||
| 410-675-8586 (Voice) | ||
| 410-276-0217 (Fax) | ||
| Contact Person: Peter J. Carnes | ||
| Summary Prepared on: 26 March 1997 | ||
| (2) | Classification Name: | Surgical instrument motors and |
| accessories/attachments. | ||
| Common or Usual Name: | Marrow Harvest aspiration needle or trephine | |
| Proprietary Name: | BioAccess Marrow Harvest System |
- The predicate devices are: (3)
- BioAccess Bone Marrow Harvest Kit 510(k) K953064 never . commercially distributed by BioAccess, Inc.
- Jamshiti Aspiration needle a pre-1976 device commercially . distributed by Pharmaseal division of Baxter International. ..............................................................................................................................................................................
- Disposable "J" Type Bone Marrow Biopsy/Aspiration Needle 510(k) . K843830 - commercially distributed by Popper & Sons. Inc.
- Hall Versipower Surgical Instrument System 510(k) K895198 know . as the CORB System formerly commercially distributed by Zimmer, Inc., discontinued due to poor sales performance.
- (4) The device is a hand-held battery powered device that penetrates the bone and allows aspiration through a hole in the bit for bone marrow harvest. The device is made from medical grade components and sold as a disposable procedure kit and a reusable motor unit.
- Penetration of the bone cavity and aspiration of marrow is the intended use (5) of the device. The device has a more narrow intended use than the predicates as they are all for biopsy, coring and aspiration. This difference is not significant to safety or efficacy as it is a subset of the indications of the predicate.
Page 24
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- (6) The device is similar in most ways to the predicates including but not limited to intended use, patient population, user population and materials. The significant difference between the BioAccess device and the predicates is the presence of battery power as an alternative to manual tools or AC power.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter J. Carnes BioAccess, Inc. 8400 Cedar Street ... Silver Spring, Maryland 20910
JUN - 3 1997
Re: K971114 Trade Name: BioAccess Marrow Harvest System Regulatory Class: I Product Code: GDM Dated: March 26, 1997 Received: March 26, 1997
Dear Mr. Carnes:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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Page 2 - Mr. Peter J. Carnes
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) 594-4595. 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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May-29-97 01:59P
の5/20・07 TUE 12:40 FAX 101 180 3002
FDA / ODE / DDF / DD I GD
পি ৩৫ র
Page_______ of
K971114 510(k) Number (if known) ._
BioAccess Marrow Harvest System Device Name: _
Indications For Use
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.
(I'lease do not write below This line.continue on another page in NFFDFD)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K971114 |
| Prescription Use | X |
|---|---|
| OR | Over-The-Counter Use |
Prescription Use (Per 21 CFR 801 109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.