(3 days)
The BD SoloShot™ IX Syringe is intended for the Aspiration and Injection of fluids.
The BD SoloShot™ IX Syringes are intended for the aspiration and injection of fluids.
The Modified Device, the subject of this 510(k), the BD SoloShot™ IX Syringe has been modified from the Predicate Device by changing to a 2-piece piston syringe. The syringe consists of a syringe barrel and one-piece plunger rod without the rubber stopper. The SoloShot™ IX Syringe has an identical permanently attached needle and identical autodisable feature. This syringe is individually blister packaged and ETO sterilized to SAL of 10-6. The intended use of the modified device remains the same as the predicate; for aspiration and injection of fluids.
The provided text describes a 510(k) submission for the BD SoloShot™ IX Syringe, which is a modified version of the predicate device, the BD Single-Fil™ Syringe. The submission focuses on demonstrating substantial equivalence to the predicate device through design verification tests.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria values in a table format. It generally states that "Design Verification tests were performed based on the risk analysis performed and the results of these tests demonstrate that the BD SoloShot™ IX Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended."
To infer acceptance criteria, one would consider the performance aspects of syringes, which typically include:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | "performed in an equivalent manner to the predicate device" |
| Safety | "is safe... when used as intended" |
| Effectiveness | "is... effective when used as intended" |
| Proper Aspiration of Fluids | Performance expected for "aspiration and injection of fluids" |
| Proper Injection of Fluids | Performance expected for "aspiration and injection of fluids" |
| Integrity of Auto-disable Feature | "identical auto-disable feature" indicates it performs as the predicate |
| Material Compatibility | "manufactured of the same materials" as the predicate |
| Sterility Assurance Level (SAL) | "ETO sterilized to SAL of 10⁻⁶" (for modified device), "SAL of 10⁻⁶" (for predicate during characterization) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the design verification tests. It also does not provide information on the country of origin of the data or whether the study was retrospective or prospective.
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)
This type of information is generally not applicable to a medical device like a syringe, where performance is evaluated through engineering tests rather than expert interpretation of data (e.g., medical images). Therefore, there were no experts used to establish ground truth in the sense of clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads). Since this is a submission for a syringe and its performance is assessed through design verification tests, adjudication methods are not relevant or 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
An MRMC comparative effectiveness study is not mentioned as this submission is for a syringe, not an AI-assisted diagnostic tool. Therefore, the concept of AI assistance and improvement of human readers is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission is for a physical medical device (syringe), not an algorithm or software. Therefore, the concept of standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" or standard for comparison is the performance of the predicate device and established engineering specifications for syringe function, sterility, and material compatibility. The document states that performance was determined by "Design Verification tests" that demonstrated "equivalent manner to the predicate device."
8. The sample size for the training set
The concept of a "training set" doesn't apply to this type of medical device submission. Training sets are relevant for machine learning or AI models, which are not involved here.
9. How the ground truth for the training set was established
As there is no training set for a machine learning model, this question is not applicable to the provided document. The "ground truth" for the device's acceptable performance is based on its ability to function equivalently to the predicate device through engineering design verification.
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510K SUMMARY OF SAFETY AND EFFECTIVENESS
1. Submitted By:
Peter Zurlo Manager, Regulatory Affairs
BD Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417-1883
Phone: 201-847-6447 201-847-4855 Fax:
-
- Device Name:
BD SoloShot IX Syringe Trade Name:
- Device Name:
Piston Syringe Common Name:
Syringe, Piston Classification Name:
Predicate Device:
BD Single-Fil Syringe
Manufactured by: Becton Dickinson and Company
3. Device Description:
The Predicate Device, the BD Single-Fil™ Syringe (K883955) is a standard 3-piece piston syringe with a permanently attached needle and with an auto-disable feature that prevents reuse of the syringe after aspiration and injection by locking the plunger rod in place after injection. The syringe consists of the syringe barrel with permanently attached needle, a plunger rod and non-latex rubber stopper. The syringe is individually blister packaged and Gamma Irradiation sterilized to SAL of 104. This syringe is intended for aspiration and injection of fluids.
The Modified Device, the subject of this 510(k), the BD SoloShot™ IX Syringe has been modified from the Predicate Device by changing to a 2-piece piston syringe. The syringe consists of a syringe barrel and one-piece plunger rod without the rubber stopper. The SoloShot™ IX Syringe has an identical permanently attached needle and identical autodisable feature. This syringe is individually blister packaged and ETO sterilized to SAL
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of 10". The intended use of the modified device remains the same as the predicate; for aspiration and injection of fluids.
Intended Use: રું.
Same intended use as the Predicate Device.
The BD SoloShot™ IX Syringe is intended for the Aspiration and Injection of fluids
Technological Charactcristics:
The Modified Device, the subject of this 510(1), The BD SoloShot™ IX Syringe Was modified by changing the plunger rod and removing the rubber plunger stopper making the syringe a 2-piece syringe ( barrel and plunger rod).
The Modified Device is manufactured of the same materials, has the same intended use and SAL of 10t as the Predicate Device.
Performance: ર.
Design Verification tests were performed based on the risk analysis performed and the results of these tests demonstrate that the BD SoloShot™ IX Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
OCT 2 8 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Zurlo Manager, Regulatory Affairs Becton Dickinson Medical Surgical 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K042934
Trade/Device Name: SoloShot™ IX Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 22, 2004 Received: October 25, 2004
Dear Mr. Zurlo:
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). 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 (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.
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Page 2 - Mr. Zurlo
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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.
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/dsma/dsmamain.html
Sincerely yours,
Olu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k)Number(if known) | K442934 |
|---|---|
| Device Name | BD SoloShot™ IX Syringe |
| Indications for Use | The BD SoloShot™ IX Syringes are intended for the aspiration and injection of fluids. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801. 109) le n (Division Sign-Off)
Division of Anesthesinlogy, General Hospital, Infection Control, Dental Devices
510(k) Number: X042934
000020
§ 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).