(69 days)
No
The summary describes a mechanical device for bone marrow harvest and does not mention any AI/ML components or functions.
No
This device is used for harvesting bone marrow, which is a diagnostic and research procedure, not a therapeutic treatment in itself.
No
The device is described as a "Marrow Harvest System" and its indicated use is for the "harvest of bone marrow," which is a procedure for collecting cells rather than diagnosing a condition.
No
The device description explicitly states it is a "hand-held battery powered device" with a "reusable motor unit" and "disposable procedure kit," indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. They are used outside the body (in vitro).
- Device Function: The BioAccess Marrow Harvest System is used to collect a specimen (bone marrow) from the body. It is a surgical/procedural device, not a device that analyzes the specimen once it's collected.
The device's purpose is the harvesting of the bone marrow, which is a step before any potential in vitro diagnostic testing might be performed on that bone marrow.
N/A
Intended Use / Indications for Use
The BioAccess Marrow Harvest System is indicated for the harvest of bone marrow from the pelvic bone cavity.
Product codes
GDM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic bone cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
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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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a seal. The seal includes an abstract image of an eagle or bird-like figure with three curved lines representing its wings or feathers. The overall design is simple and professional, reflecting the department's role in public health and human services.
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.
3
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
4
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)