(14 days)
The Manan™ Biopsy Set for Bone and Bone Marrow is intended for the purpose of harvesting bone and/or bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.
In addition to the above, the pediatic bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiating resuscitative infusion or for aspirating marrow in pediatic patients.
These devices are intended for the purpose of harvesting bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone marrow speciment(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.
In addition to the above, the pediatric bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiative infusion or for aspirating marrow in pediatric patients.
This document is a 510(k) summary for the Manan™ Biopsy Set for Bone and Bone Marrow, and a clearance letter from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against predefined acceptance criteria.
Therefore, I cannot provide the requested information based on the input provided.
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3 1998 FEB
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K990196
510(k) SUMMARY
Sainesville Florida TEL: 352/338-0440 FAX: 352/338-0662
| APPLICANT: | Medical Device Technologies, Inc.4445-310 SW 35th TerraceGainesville, FL 32608 |
|---|---|
| CONTACT: | Karl SwartzQuality Assurance Manager |
| TELEPHONE: | (352)338-0440fax (352)338-0662 |
| TRADE NAMES: | Manan™ Biopsy Set for Bone and Bone marrow |
| COMMON NAME: | Bone and/or bone marrow aspiration/biopsy needles |
| CLASSIFICATION NAME: | Needle, Biopsy, Cardiovascular, No. 79DWO |
| SUBSTANTIAL EQUIVALENCE: |
| Company Name | Product Name | 510(k) No |
|---|---|---|
| Medical Device Technologies, Inc. | Bone Biopsy Needles | K961959 |
| Manan Medical Products | Bone Marrow Biopsy | K890925 |
| Manan Medical Products | Bone Biopsy Needle | K902177 |
| Manan Medical Products | Pediatric Bone Marrow Needle | K962001 |
DESCRIPTION OF DEVICE:
CLAS
SUBS.
These devices are intended for the purpose of harvesting bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone marrow speciment(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.
In addition to the above, the pediatric bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiative infusion or for aspirating marrow in pediatric patients.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 FEB
Mr. Karl Swartz Quality Assurance Manager Medical Device Technologies, Incorporated 4445-310 SW 35th Terrace Gainesville, Florida 32608
Re: K980196
Trade Name: Manan™ Biopsy Set for Bone and Bone Marrow Regulatory Class: II Product Code: KNW Dated: January 19, 1998 Received: January 20, 1998
Dear Mr. Swartz:
We have reviewed vour Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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. Swartz
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
Sincerely yours,
[signature]
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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- 352/328-0662
Page_l_of_1_
510(k) Number (if known):
Device Name: Manan™ Biopsy Set for Bone and Bone Marrow
Indications for Use:
The Manan™ Biopsy Set for Bone and Bone Marrow is intended for the purpose of harvesting bone and/or bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient. --------
In addition to the above, the pediatic bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiating resuscitative infusion or for aspirating marrow in pediatic patients.
(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 | K980196 |
Prescription Use X
(Per 21 CFR 801.109)
OR Over-The-Counter Use________________
(Optional Format 1-2-96)
§ 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.