(76 days)
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Not Found
No
The summary describes a mechanical instrument kit for bone and marrow collection and does not mention any AI or ML components or functions.
No
The device is described as an instrument kit for collecting bone and marrow, with components for cutting tissue, aspiration, and extruding tissue. Its purpose is for collection, not for treating a disease or condition.
No
The device description indicates that the trocar is used to cut tissue, the suction connector converts the system into an aspiration handle, and the plunger extrudes tissue. These are all actions related to collecting bone and marrow samples, not to diagnosing a condition.
No
The device description explicitly mentions a "Bone and Marrow Collection System (BMCS) Instrument Kit" and describes physical components like a "trocar," "suction connector," and "plunger," indicating it is a hardware device with instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's function in a surgical procedure involving bone and soft tissue. It's used for cutting, reflecting tissue, placing a system on bone, aspiration, and extruding tissue. These are all actions performed on the patient's body, not on samples from the patient's body for diagnostic purposes.
- Device Description: The description "Bone and Marrow Collection System (BMCS) Instrument Kit" further supports its use in a collection procedure, not a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural and related to collecting tissue from the body.
N/A
Intended Use / Indications for Use
To be used with the Bone and Marrow Collection System™ (BMCS). The trocar is used to cut and reflect soft-tissue allowing the BMCS to be placed on bone, the suction connector for converting the BMCS into an aspiration handle and the plunger for extruding tissue from the BMCS.
Product codes
GEY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone, soft-tissue
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
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(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 § 878.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
W. Casey Fox, Ph.D., P.E. President BME Medical Enterprises, Inc. 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245
Re: K971782
Trade Name: Bone and Marrow Collection System Kit Regulatory Class: I Product Code: GEY Dated: May 13, 1997 Received: May 14, 1997
JUL 2 9 1997
Dear Dr. Fox:
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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
1
Page 2 - W. Casey Fox, Ph.D., P.E.
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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Indication For Use
Page 1 of 1
K971782 510(k) Number (if Known):
Device Name: Bone and Marrow Collection System (BMCS) Instrument Kit
Indications for use: To be used with the Bone and Marrow Collection System™ (BMCS). The trocar is used to cut and reflect soft-tissue allowing the BMCS to be placed on bone, the suction connector for converting the BMCS into an aspiration handle and the plunger for extruding tissue from the BMCS.
(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 | K971782 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)