(14 days)
Not Found
No
The description focuses entirely on the mechanical and aspiration-based function of the device for harvesting bone and bone marrow specimens. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is intended for harvesting bone and/or bone marrow specimens and for obtaining access into medullary cavities, which are diagnostic or access purposes, not therapeutic.
No
The device is used to harvest bone and/or bone marrow specimens. These specimens are then used for diagnostic purposes, but the device itself is for specimen collection, not diagnosis. The text also mentions its use for initiating resuscitative infusion in pediatric patients, which is a therapeutic, not diagnostic, use.
No
The device description clearly outlines a physical device with mechanical components (cutting surfaces, cannulas, syringe fittings) used for harvesting bone and bone marrow specimens. There is no mention of software as part of the device's function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the device is used for harvesting bone and/or bone marrow specimens and obtaining access into medullary cavities. This is a procedure performed on the patient's body to collect a sample or provide access for infusion.
- No Analysis: The description focuses on the collection of the sample, not on any analysis or testing of the sample itself. An IVD device would typically involve reagents, analyzers, or other components used to perform a diagnostic test on the collected sample.
The Manan™ Biopsy Set for Bone and Bone Marrow is a surgical/procedural device used for obtaining biological samples from the body. It is not used to perform a diagnostic test on those samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone and bone marrow, medullary cavities
Indicated Patient Age Range
Not Found. Mentions "pediatric patients".
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.
K961959, K890925, K902177, K962001
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
§ 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.
0
3 1998 FEB
Image /page/0/Picture/1 description: The image shows a logo with the letters "AMD" in white against a black background. The letters are bold and stylized, with a modern, geometric design. Below the letters, there are three horizontal lines, also in white, that appear to be part of the logo. The overall impression is of a sleek and professional brand identity.
K990196
510(k) SUMMARY
Sainesville Florida TEL: 352/338-0440 FAX: 352/338-0662
| APPLICANT: | Medical Device Technologies, Inc.
4445-310 SW 35th Terrace
Gainesville, FL 32608 |
|--------------------------|----------------------------------------------------------------------------------------|
| CONTACT: | Karl Swartz
Quality Assurance Manager |
| TELEPHONE: | (352)338-0440
fax (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.
1
Image /page/1/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.
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.
2
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
3
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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)