(28 days)
Not Found
Not Found
No
The description details a simple mechanical syringe for fluid aspiration and does not mention any computational or analytical capabilities.
No.
The device is used for aspirating body fluids, which is a diagnostic or procedural step, not a therapeutic intervention. Its intended use states "aspiration of bone marrow, autologous blood, plasma, or other body fluids," which are collection activities.
No
The intended use of the device is for aspiration of body fluids, which is a collection activity, not a diagnostic one. There is no mention of analysis or interpretation of the collected fluids for disease detection or diagnosis.
No
The device description clearly outlines physical components (calibrated hollow barrel, moveable plunger, male connector nozzle) which are hardware, not software.
Based on the provided information, the Synthes Bone Marrow Aspiration (BMA) Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration of body fluids (bone marrow, blood, plasma, etc.). This is a procedure for collecting samples from the body.
- Device Description: The description details a syringe for withdrawing fluids. This is a tool for collection, not for testing or analyzing the collected sample in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used for testing, analysis, or diagnosis of a condition based on the collected sample. IVDs are designed to perform tests on biological specimens.
The device is a tool for sample collection, which is a step that might precede an in vitro diagnostic test, but the syringe itself is not the diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Bone Marrow Aspiration (BMA) Syringe is intended for aspiration of bone marrow, autologous blood, plasma, or other body fluids.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The syringe consists of a calibrated hollow barrel and a moveable plunger. At the distal end of the syringe there is a male connector nozzle for fitting the female connector (hub) of a single lumen needle. The syringe can be used for withdrawing body fluids.
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.
Not Found
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters, with a registered trademark symbol to the right of the word. To the left of the word is a circular logo with a design inside. A horizontal line is located underneath the word.
| 3.0 | 510(k) Summary | K051720 | Page 1 of 1 |
|---|---|---|---|
| Sponsor: | Synthes (USA) | ||
| 1302 Wrights Lane East | |||
| West Chester, PA 19380 | |||
| (610) 719-5000 | |||
| Device Name: | Synthes (USA) Bone Marrow Aspiration (BMA) Syringe | ||
| Classification: | Class II, 21 CFR §888.5860 | ||
| Piston Syringe | |||
| Predicate Device: | Merit Medical Systems, Disposable Coronary Control Syringe | ||
| Wright Medical Technologies, Bone Graft Syringe | |||
| Device Description: | The syringe consists of a calibrated hollow barrel and a moveable | ||
| plunger. At the distal end of the syringe there is a male connector | |||
| nozzle for fitting the female connector (hub) of a single lumen | |||
| needle. The syringe can be used for withdrawing body fluids. | |||
| Intended Use: | The Synthes Bone Marrow Aspiration (BMA) Syringe is intended | ||
| for aspiration of bone marrow, autologous blood, plasma, or other | |||
| body fluids. | |||
| Substantial | |||
| Equivalence: | Documentation is provided which demonstrates that Synthes Bone | ||
| Marrow Aspiration (BMA) Syringe is substantially equivalent* to | |||
| other legally marketed devices. | |||
| *The term “substantial equivalence” as used in the 510(k) | |||
| notification is limited to the definition of substantial equivalence | |||
| found in the Food, Drug and Cosmetic Act, as amended and as | |||
| applied under 21 CRF 807, Subpart E, under which a device can be | |||
| marketed without pre-market approval or reclassification;. A | |||
| determination of substantial equivalency under this notification is | |||
| not intended to have any bearing whatsoever on the resolution of | |||
| patent infringement suits or any other patent matters. No | |||
| statements related to, or in support of substantial equivalence | |||
| herein shall be construed as an admission against interest under the | |||
| US Patent Laws or their application by the courts. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes extending upwards. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.
Public Health Service
JUL 25 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K051720
Trade/Device Name: Synthes (USA) Bone Marrow Aspiration (BMA) Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 23, 2005 Received: June 27, 2005
Dear Ms. Anderson:
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). and cosmetic rever (10) was 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 may 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 r read be action and 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 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.
2
Page 2 - Ms. Kathy Anderson
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 entitled, "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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a registered trademark symbol to the right of the word. A horizontal line is present below the word.
:
Page 1
| Indications for Use | |
|---|---|
| -- | --------------------- |
| 510(k) Number (if known): | KOS 1720 |
|---|---|
| Device Name: | Synthes (USA) Bone Marrow Aspiration (BMA) Syringe |
| Indications: | The Synthes Bone Marrow Aspiration (BMA) Syringe is intended for aspiration of bone marrow, autologous blood, plasma, or other body fluids. |
| Prescription Use ____________ X
(Per 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use ____________
(21 CFR 807 Subpart C) |
| --------------------------------------------------------------- | -------- | ------------------------------------------------------------- |
|---|
(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
and Neurological Devices