(28 days)
The Synthes Bone Marrow Aspiration (BMA) Syringe is intended for aspiration of bone marrow, autologous blood, plasma, or other body fluids.
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.
The provided text is a 510(k) summary for the Synthes (USA) Bone Marrow Aspiration (BMA) Syringe. It focuses on demonstrating "substantial equivalence" to predicate devices, a regulatory pathway under the FDA. For medical devices pursuing this pathway, the "acceptance criteria" and "study" described in your request are typically not present in the same way as for novel devices undergoing rigorous performance validation. Instead, the focus is on showing similarity in design, materials, and intended use to existing, legally marketed devices.
Therefore, the specific information requested about acceptance criteria and study details (like sample size, ground truth, expert opinions, MRMC studies, standalone performance) for an AI/device performance validation does not apply directly to this 510(k) submission for a non-AI, piston syringe device.
Here's how to address your points based on the provided text's context:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense for this 510(k). The provided text does not define specific performance acceptance criteria for the Synthes BMA Syringe beyond meeting the functional requirements expected of a "Piston Syringe" (21 CFR §888.5860) and demonstrating "substantial equivalence" to predicate devices.
- Implicit acceptance criteria: The device must function as a syringe for "aspiration of bone marrow, autologous blood, plasma, or other body fluids" reliably and safely, consistent with its classification and the performance of its predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This 510(k) summary does not describe a clinical performance study with a "test set" in the context of AI or advanced diagnostic devices. "Substantial equivalence" is typically demonstrated through engineering analyses, bench testing, and comparison to predicate devices, not large-scale clinical trials with defined test sets for performance metrics like sensitivity/specificity.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment by experts for a test set is mentioned or required for this type of device's 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. An MRMC study is not relevant for a simple piston syringe. This device is not an AI-powered diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a physical syringe, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth (in the sense of a medical outcome for comparison) is not a concept applied in this 510(k) submission. Device performance is assessed based on engineering specifications and intended function.
8. The sample size for the training set
- Not Applicable. There is no "training set" for this device, as it is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth establishment is relevant to this 510(k) submission.
Summary based on the provided 510(k) document:
The 510(k) summary for the Synthes (USA) Bone Marrow Aspiration (BMA) Syringe demonstrates "substantial equivalence" to legally marketed predicate devices, not by meeting specific performance acceptance criteria from a clinical study, but by showing that its design, materials, and intended use are similar to existing devices. The key "acceptance criteria" here is the regulatory determination by the FDA that the device is "substantially equivalent" to its predicates based on the submitted documentation, allowing it to be marketed. This regulatory pathway does not typically involve the types of studies or performance metrics you've inquired about, which are more common for novel or AI-driven diagnostic devices.
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| 3.0 | 510(k) Summary | K051720 | Page 1 of 1 |
|---|---|---|---|
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5000 | ||
| Device Name: | Synthes (USA) Bone Marrow Aspiration (BMA) Syringe | ||
| Classification: | Class II, 21 CFR §888.5860Piston Syringe | ||
| Predicate Device: | Merit Medical Systems, Disposable Coronary Control SyringeWright Medical Technologies, Bone Graft Syringe | ||
| Device Description: | The syringe consists of a calibrated hollow barrel and a moveableplunger. At the distal end of the syringe there is a male connectornozzle for fitting the female connector (hub) of a single lumenneedle. The syringe can be used for withdrawing body fluids. | ||
| Intended Use: | The Synthes Bone Marrow Aspiration (BMA) Syringe is intendedfor aspiration of bone marrow, autologous blood, plasma, or otherbody fluids. | ||
| SubstantialEquivalence: | Documentation is provided which demonstrates that Synthes BoneMarrow Aspiration (BMA) Syringe is substantially equivalent* toother legally marketed devices. | ||
| *The term “substantial equivalence” as used in the 510(k)notification is limited to the definition of substantial equivalencefound in the Food, Drug and Cosmetic Act, as amended and asapplied under 21 CRF 807, Subpart E, under which a device can bemarketed without pre-market approval or reclassification;. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts. |
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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.
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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
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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) |
|---|---|---|
| --------------------------------------------------------------- | -------- | ------------------------------------------------------------- |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of General, Restorative
and Neurological Devices
§ 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).