The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe device is a sterile two-piece piston syringe designed to deliver a single fixed dose. It features a permanently attached hypodermic needle and auto-disable feature that prevents reuse of the syringe by locking the plunger rod in place after injection. The SoloShot™ Mini Syringe consists of a syringe barrel, a one-piece plunger rod (without rubber stopper), a clip affixed to the plunger rod and a integral needle is protected with a shield cover. The clip activates the auto-disabled feature, preventing re-use of the syringe is individually blister packaged and ETO sterilized to SAL of 10-6 .

AI/ML Overview

The provided document is a 510(k) summary for the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe, which is a medical device. This type of document is used to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific performance criteria in a clinical setting in the way a diagnostic AI device might.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of device and submission. This is a syringe, and its performance is evaluated through bench testing, biocompatibility, and sterilization, not through clinical trials where human readers or AI algorithms analyze data for diagnostic purposes.

Here's an attempt to answer the questions based on the provided document, highlighting what is applicable and what isn't:

1. A table of acceptance criteria and the reported device performance

The document states that "In all instances, the BD SoloShot™ Mini Syringe functioned as intended and results observed met the predefined acceptance criteria." However, the exact numerical acceptance criteria for each test and the precise numerical results are not provided in this summary. The summary only lists the types of tests performed.

Acceptance Criterion (Type of Test)	Reported Device Performance
Leakage	Met predefined acceptance criteria
Dose Accuracy	Met predefined acceptance criteria
Dead Space	Met predefined acceptance criteria
Maximum Usable Capacity	Met predefined acceptance criteria
Activation Forces	Met predefined acceptance criteria
Cannula Pull Force	Met predefined acceptance criteria
Shield Pull Force	Met predefined acceptance criteria
Deactivation Volume/Force to defeat the auto-destruct feature	Met predefined acceptance criteria
Scale Mark Permanency	Met predefined acceptance criteria
Package Integrity	Met predefined acceptance criteria
Biocompatibility (Cytotoxicity, Hemolysis, Acute Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Pyrogenicity, Chemical Extractables Analysis, Primary Dermal Irritation)	Passed ISO 10993 testing; Non-pyrogenic, Non-Toxic
Sterilization (Ethylene Oxide)	Requalification of sterilization validation met SAL 10-6
Compliance to Standards (ISO 10993-1, ISO 11135, ISO 7886-3, ISO 7886-1, ISO 7864, ISO 9626, ISO 6009)	Functioned as intended and results met predefined acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. These tests are "bench performance" tests, not clinical studies involving patient data. The "sample size" would refer to the number of syringes tested for each performance characteristic, which is typically standard practice for device validation but not detailed here.

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 is not applicable to this type of device. "Ground truth" in the context of expert consensus is relevant for diagnostic devices that interpret images or other patient data. For a syringe, performance is measured against objective physical and chemical standards, not expert interpretation of patient-related data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are used in studies where there is subjective interpretation (e.g., by experts) to resolve disagreements. Here, the performance is measured objectively.

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

This is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human readers and AI assistance. This device is a syringe, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This is a physical medical device (syringe), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, "ground truth" refers to established engineering, chemical, and biological standards (e.g., ISO standards for sterility, biocompatibility, and physical performance). The device's performance is measured against these objective standards.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a syringe's performance evaluation. Training sets are used in machine learning for AI algorithms.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set for a syringe, there is no ground truth to establish for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 15, 2020

Becton, Dickinson, and Company Avital Merl Director, Regulatory Affairs 1 Becton Drive Franklin Lakes, New Jersey 07417

Re: K201234

Trade/Device Name: BD SoloShot Mini Syringe/ BD Auto Disable Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: July 14, 2020 Received: July 15, 2020

Dear Avital Merl:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement on last page
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510(k) Number (if known)
Device Name	BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe
Indications for Use (Describe)	The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of fluids.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

Page 1 of 1 FDA

PSC Publishing Services (301) 443-6740 EF

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510(k) SUMMARY

BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe

Becton Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417

Phone: (201) 847-4739 Fax: (201) 847 5307

Contact Person: Avital Merl Date Prepared: July 14,2020

Name of Device: BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe Common or Usual Name: Piston Syringe Classification Name: Piston Syringe; 21 CFR §880.5860 Requlatory Class: Class II device Product Code: FMF

Predicate Device: BD SoloShot™ IX Syringe 510(k) Reference: K042934 Classification Name: Piston Syringe; 21 CFR §880.5860 Requlatory Class: Class II device Product Code: FMF

Purpose of the Special 510(k) notice.

The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is a modification to BD SoloShot™ IX Syringe.

Intended Use

The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of fluids.

Device Description

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Technological Characteristics

Both the subject and predicate device operate as a piston syringe and are used for general purpose aspiration and injection of fluids. The system components and operational principle of the subject and predicate device are the same. The following technological differences exist between the subject and predicate devices:

Dimensions of the barrel, plunger rod, clip, shield component, and packaging .
. Minor material modifications to the scale mark ink and the barrel and shield resins.

A comparison of the subject and predicate device is summarized in the Table below.

	Subject Device:BD SoloShot™ Mini Syringe/BD Auto Disable Syringe	Predicate Device:BD SoloShot™ IX Syringe	Comparison
510(k) Number	K201234	K042934
Intended Use	Intended for aspiration andinjection of fluids.	Intended for aspiration andinjection of fluids.	Same
Technological Characteristics
Syringe Type	2 Piece (miniature size barreland plunger)	2 Piece (barrel and plunger)	Different; Validatedwith Benchperformance &Sterilizationvalidation
Reuse Prevention(Safety) Feature	Auto-disabled (Miniature size),prevents syringe re-use	Auto-disabled, preventssyringe re-use	Different; Validatedwith Benchperformance &Sterilizationvalidation
Dose Saving Feature	Low Dead Space/Volume	Low Dead Space/Volume	Same
Integrated Needle	Yes	Yes	Same
DoseSetting/Volumes	Fixed doses: 0.5 mL	Fixed doses: 0.5 mL or 1.0mL	Same
Needle Size (Gaugex Length)	23G X 1"24G x 3/4"25G x 1"25G x 5/8"	22G X 1"23G X 1"24G x 3/4"25G x 1"25G x 5/8"	Same
Component Materials
Barrel Material	Plastic	Plastic	Same; Minormodificationsvalidated withBiocompatibility
Plunger Material	Plastic + Colorant (blue, violet, orange)	Plastic + Colorant (black, blue, violet, orange)	Same
Clip	Stainless steel	Stainless steel	Same
Integrated Cannula	Stainless Steel	Stainless Steel	Same
Shield	Plastic	Plastic	Same; Minormodificationsvalidated withBiocompatibility
Biocompatibility
Biocompatibility	Passed ISO 10993 testing;Non-pyrogenic, Non Toxic	Passed ISO 10993 testing;Non-pyrogenic, Non Toxic	Same
Sterilization	Ethylene Oxide (SAL 10-6)	Ethylene Oxide (SAL 10-6)	Same
Shelf Life	5 years	5 years	Same

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Performance Data

BD performed the following bench, biocompatibility, and sterilization testing to support the modifications of the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe. The results of these analyses demonstrate that the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe performed in an equivalent manner to the predicate device.

Bench Performance ●
- o Leakage, Dose Accuracy, Dead Space, Maximum Usable Capacity, Activation Forces, Cannula Pull Force, Shield Pull Force, Deactivation Volume/ Force to defeat the auto-destruct feature, Scale Mark Permanency, and Package Integrity
Material Biocompatibility Performance ●
- o Cytotoxicity, Hemolysis, Acute Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Pyrogenicity, Chemical Extractables Analysis, and Primary Dermal Irritation
Sterilization Performance .
- o Requalification of sterilization validation
Compliance to Standards ●
- o ISO 10993-1: 2009/2018, ISO 11135: 2004, ISO 7886-3: 2005, ISO 7886-1:1993, ISO 7864:1993, ISO 9626:1991, ISO 6009:1992

In all instances, the BD SoloShot™ Mini Syringe functioned as intended and results observed met the predefined acceptance criteria.

Conclusion

The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is as safe and effective as the BD SoloShot™ IX Syringe. The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe has the same intended uses and similar technological characteristics, and principles of operation as its predicate device. The technological differences between the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe and its predicate device raise no new issues of safety or effectiveness. Bench, Biocompatibility, and Sterilization performance data demonstrate that the BD SoloShot™ Mini Syringel BD Auto Disable Syringe is as safe and effective as the BD SoloShot™ IX Syringe. Thus, the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is substantially equivalent.

Regulation Number and Section

§ 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).