(90 days)
Not Found
No
The summary describes a mechanical device for bone marrow harvesting and does not mention any AI or ML components or functionalities.
No
The device is described as harvesting bone marrow, which is a collection or diagnostic procedure, not a therapeutic treatment for a disease or condition. The text focuses on obtaining samples and does not mention any therapeutic use.
No
The device is described as harvesting/collecting bone marrow, not diagnosing conditions based on bone marrow.
No
The device description explicitly lists hardware components: a battery-powered handle, an aspiration chamber, a flexible aspiration shaft, and an access guide.
Based on the provided information, the MarrowMiner is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "harvesting bone marrow." This is a procedure performed on the patient's body to collect a sample.
- Device Description: The description details a device used for physically collecting bone marrow through aspiration and rotation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside of the body (in vitro) to provide information about a patient's health. The MarrowMiner's function is to obtain the specimen, not to analyze it.
The MarrowMiner is a surgical or procedural device used for bone marrow collection.
N/A
Intended Use / Indications for Use
For harvesting bone marrow.
Product codes (comma separated list FDA assigned to the subject device)
GDM, GAA
Device Description
The MarrowMiner is a device intended for harvesting bone marrow. The StemCor MarrowMiner bone marrow collection system is comprised of four components; a MarrowMiner battery powered handle, an aspiration chamber, a flexible aspiration shaft, and an access guide. The tip of the flexible aspiration shaft rotates and aspirates bone marrow. The device has been shown in animal studies to obtain adequate bone marrow samples without compromising the iliac crest integrity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K961902, K964073, K971783, K043523, K062833
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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PREMARKET NOTIFICATION [510(K)] SUMMARY
| June, 2007 | K071732 | |
|---|---|---|
| Trade Name: | StemCor Systems, Inc. MarrowMiner | |
| Common Name: | Biopsy instrument | |
| Classification Name: | Instrument, biopsy (per 21 CFR section 876.1075) | |
| Manufacturer's Name: | StemCor Systems, Inc. | |
| 801 Hermosa Way | ||
| Menlo Park, CA 94025 | SEP 24 2007 | |
| Corresponding Official: | Sharon Rockwell | |
| Consultant | ||
| 5582 Chalon Road | ||
| Yorba Linda, CA 92886 | ||
| Phone: (714) 695-9269 | ||
| Fax: (714) 779-1239 | ||
| Predicate Device(s): | Biomedical Eng, Inc. BoneHog/Excaliber, K961902, K964073, K971783. | |
| Medical Device Technologies, Inc. InterV SnareLok Bone Marrow Biopsy Needle, K043523. | ||
| Vidacare Bone Marrow Aspiration Set, K062833 | ||
| Device Description: | The MarrowMiner is a device intended for harvesting bone marrow. The StemCor MarrowMiner bone marrow collection system is comprised of four components; a MarrowMiner battery powered handle, an aspiration chamber, a flexible aspiration shaft, and an access guide. The tip of the flexible aspiration shaft rotates and aspirates bone marrow. The device has been shown in animal studies to obtain adequate bone marrow samples without compromising the iliac crest integrity. | |
| Intended Use: | For harvesting bone marrow. | |
| Technological | ||
| Characteristics: | Aspiration module and flexible shaft allow the marrow to be collected under controlled vacuum through a single puncture until the desired volume is collected. |
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2007
Stemcor Systems, Inc. % Rockwell & Associates Ms. Sharon Rockwell Consultant, Regulatory Affairs 5582 Chalon Road Yorba Linda, California 92886
Re: K071732
Trade/Device Name: StemCor Systems, Inc. MarrowMiner Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: GDM, GAA Dated: August 30, 2007 Received: August 31, 2007
Dear Ms. Rockwell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
2
Page 2 - Ms. Sharon Rockwell
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation ventitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2141 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely vours.
Par Vdo Rmo De
Mark N. Melkerson 241.03
Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ KO7l732
Device Name: StemCor Systems, Inc. MarrowMiner
Indications for Use:
The MarrowMiner is intended for harvesting bone marrow.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliman
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number KO
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