(69 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is described as a syringe for aspiration and injection of fluids, which is a delivery mechanism for substances, and not a device intended to treat or manage a disease or condition itself.
No
The device is described as a syringe for the aspiration and injection of fluids, designed to deliver a fixed dose and prevent reuse. Its intended use and description focus on fluid delivery, not on diagnosing medical conditions or diseases.
No
The device description clearly outlines physical components (syringe barrel, plunger rod, needle, clip, shield cover) and mentions sterilization and bench testing, indicating it is a hardware device.
Based on the provided information, the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for aspiration and injection of fluids." This describes a device used directly on or in a patient for delivering or withdrawing substances, which is a typical function of a medical device, not an IVD.
- Device Description: The description details a syringe with a needle and an auto-disable feature. This is consistent with a device used for administering injections or drawing fluids from a living organism.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease. IVDs are designed for testing samples, not for direct patient intervention like injection.
- Performance Studies: The performance studies focus on bench performance, biocompatibility, and sterilization, which are relevant for a medical device used in direct patient contact, but not typically the primary performance metrics for an IVD (which would focus on analytical and clinical performance related to testing specimens).
In summary, the BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is a medical device intended for direct patient use (injection/aspiration), not for testing specimens in vitro.
N/A
Intended Use / Indications for Use
The BD SoloShot™ Mini Syringe/ BD Auto Disable Syringe is intended for aspiration and injection of fluids.
Product codes
FMF
Device Description
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.
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)
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
- 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
- Cytotoxicity, Hemolysis, Acute Systemic Toxicity, Intracutaneous Reactivity, Sensitization, Pyrogenicity, Chemical Extractables Analysis, and Primary Dermal Irritation
- Sterilization Performance
- Requalification of sterilization validation
- Compliance to Standards
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
1
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
2
Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page |
| ------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------- |
|---|
| 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)
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
3
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
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 .
4
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 and
injection of fluids. | Intended for aspiration and
injection of fluids. | Same |
| Technological Characteristics | | | |
| Syringe Type | 2 Piece (miniature size barrel
and plunger) | 2 Piece (barrel and plunger) | Different; Validated
with Bench
performance &
Sterilization
validation |
| Reuse Prevention
(Safety) Feature | Auto-disabled (Miniature size),
prevents syringe re-use | Auto-disabled, prevents
syringe re-use | Different; Validated
with Bench
performance &
Sterilization
validation |
| Dose Saving Feature | Low Dead Space/Volume | Low Dead Space/Volume | Same |
| Integrated Needle | Yes | Yes | Same |
| Dose
Setting/Volumes | Fixed doses: 0.5 mL | Fixed doses: 0.5 mL or 1.0
mL | Same |
| Needle Size (Gauge
x 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; Minor
modifications
validated with
Biocompatibility |
| 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; Minor
modifications
validated with
Biocompatibility |
| 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 |
5
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.