(30 days)
The BD Preset™ Syringe & BD A-Line™ Syringe are sterile, single use medical devices specifically intended to be used for the collection of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry. The device is intended to be used by trained healthcare professionals.
The BD Preset™ Syringe & BD A-Line™ Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The BD A-Line™ Syringe is specifically designed for aspiration of blood samples from arterial lines. The BD Preset™ Syringe is offered with and without a pre-attached Eclipse™ needle and is specifically designed to preset a desired volume but permits aspiration when necessary. It also includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling. The syringe is individually packaged, and Gamma sterilized with an SAL of 10-6.
The provided text describes a Special 510(k) premarket notification for the BD Preset™ Syringe & BD A-Line™ Syringe. This submission focuses on demonstrating substantial equivalence to a predicate device after minor modifications.
Here's a breakdown of the acceptance criteria and the study conducted, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly present a table of acceptance criteria defined as numerical thresholds alongside reported device performance for blood gas measurements or similar clinical metrics. This submission focuses on bench, biocompatibility, and sterilization testing to demonstrate that the modified device performs equivalently to the predicate, and that the changes introduce no new safety or effectiveness issues.
Instead, the "acceptance criteria" are implied to be meeting the performance of the predicate device and relevant international standards. The "reported device performance" is a general statement that the device functioned as intended and demonstrated acceptable performance.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Performance | Equivalent to predicate; meets functional requirements for: | "Functioned as intended and results demonstrated acceptable performance for the subject device." (Equivalent to predicate) |
| - Tip cap leak | ||
| - Shield Activation Force | ||
| - Shield Unlocking Force | ||
| - Shield Removal | ||
| - Plunger Separation Force | ||
| - Plunger Activation Force | ||
| - Leak Past Stopper | ||
| - Needle Cannula Pull Out Force | ||
| - Ship and Leak | ||
| - Heparin Activity | ||
| Biocompatibility | Passed ISO 10993 testing (various parts) | "Passed ISO 10993 testing" |
| - Cytotoxicity | ||
| - Sensitization | ||
| - Intracutaneous Reactivity | ||
| - Acute Systemic Toxicity | ||
| - Material Mediated Pyrogenicity | ||
| - Hemolysis | ||
| - Color Migration | ||
| - Extractables and Leachables | ||
| Sterilization | Requalification of sterilization validation; maintains SAL of 10-6 | "Requalification of sterilization validation" |
| Compliance to Standards | Adherence to listed ISO and ASTM standards | "Compliance to Standards" (Listed standards met) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each of the bench, biocompatibility, or sterilization tests. It only lists the types of tests conducted.
- Data Provenance: The data are internal company testing results ("BD performed the following bench, biocompatibility, and sterilization testing"). The document does not specify country of origin for the data (e.g., US, Europe, etc.) or whether it was retrospective or prospective, though performance testing of a new/modified device would generally be prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission (510(k) for a medical device like a syringe) does not involve establishing ground truth through expert review in the way a diagnostic AI submission would. The "ground truth" for the performance tests listed (e.g., tip cap leak, heparin activity) would be established by the physical and chemical properties of the materials and the manufacturing process, verified by standard laboratory testing procedures. There's no interpretive component requiring multiple human experts.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic interpretation study. The tests performed are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic devices where human reader performance (e.g., radiologists interpreting images) is being evaluated for improvement with or without AI assistance. This submission is for a blood collection syringe, a physical medical device, not a diagnostic interpretation system. Therefore, this type of study was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic or AI device. The "performance data" refers to the physical and chemical performance of the syringe.
7. The Type of Ground Truth Used
The "ground truth" for the performance "studies" (which are laboratory tests rather than clinical trials with patient outcomes) is based on:
- Established physical and chemical test methods (e.g., ASTM, ISO standards).
- Functional specifications for the device (e.g., desired plunger force, leak-free operation).
- The performance of the legally marketed predicate device (demonstrating equivalence).
Essentially, the "ground truth" is that the device must function safely and effectively according to engineering and material science principles, and meet the performance standards of its predicate.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 25, 2020
Becton, Dickinson and Company Avital Merl Director, Regulatory Affairs 1 Becton Drive Franklin Lakes, NJ 07417
Re: K202446
Trade/Device Name: BD Preset™ Syringe & BD A-Line™ Syringe Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: August 25, 2020 Received: August 26, 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 and Part 809); 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 medical devices and radiation-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,
Marianela Perez- Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202446
Device Name BD Preset™ Syringe & BD A-Line™ Syringe
Indications for Use (Describe)
The BD Preset™ Syringe & BD A-Line™ Syringe are sterile, single use medical devices specifically intended to be used for the collection of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry. The device is intended to be used by trained healthcare professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
BD Preset™ Syringe & BD A-Line™ 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: September 24, 2020
510(k) Number: K202446
Name of Device: BD Preset™ Syringe & BD A-Line™ Syringe Common or Usual Name: Blood Specimen Collection Device Classification Name: Blood Specimen Collection Device: 21 CFR §862.1675 Requlatory Class: Class II device Product Code: JKA
Predicate Device: BD Preset™ & BD A-Line™ Blood Collection Syringe 510(k) Reference: K022426 Classification Name: Blood Specimen Collection Device: 21 CFR §862.1675 Requlatory Class: Class II device Product Code: JKA
Purpose of the Special 510(k) notice.
The BD Preset™ Syringe & BD A-Line™ Syringe is a modification to BD Preset™ & BD A-Line™ Blood Collection Syringe predicate device.
Intended Use
The BD Preset™ Syringe & BD A-Line™ Syringe are sterile, single use medical devices specifically intended to be used for the collection of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, cooximetry. The device is intended to be used by trained healthcare professionals.
Device Description
The BD Preset™ Syringe & BD A-Line™ Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The BD A-Line™ Syringe is specifically designed for aspiration of blood samples from arterial lines. The BD Preset™ Syringe is offered with and without a pre-attached Eclipse™ needle and is specifically designed to preset a desired volume but permits aspiration when necessary. It also includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling. The syringe is individually packaged, and Gamma sterilized with an SAL of 10-6.
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Technological Characteristics
Both the subject and predicate device are designed to collect whole blood specimens for diagnostic testing. 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:
- . Material modifications to the device components
- . Labeling revisions
- New pre-attached safety needle configuration offering .
A comparison of the subject and predicate device is summarized in the Table below.
| SUBJECT DEVICE:BD Preset™ Syringe & BD A-Line™ Syringe | PREDICATE DEVICE:BD Preset™ & BD A-Line™Blood Collection Syringe | COMPARISON | |
|---|---|---|---|
| 510(k) Submission | |||
| Pending | K022426 | N/A | |
| Indications for Use Statement | |||
| Sterile, single use medicaldevices specifically intended tobe used for the collection ofwhole blood specimens for thepurpose of in vitro diagnostictesting which may include: pH,blood gases, electrolytes(including ionized calcium),metabolytes, co-oximetry. Thedevice is intended to be usedby trained healthcareprofessionals. | intended to collect whole bloodspecimens for diagnostictesting which may include: pH,blood gases, electrolytes(including ionized calcium),metabolytes, co-oximetry, andother tests. | Sameintended use;Minorclarifications | |
| Technological Characteristics | |||
| Syringe Components | Barrel, plunger with pre-attachedstopper, and tip cap | Barrel, plunger with pre-attachedstopper, and tip cap | Same |
| Configuration withPre-attached Needle | Yes (safety needle) | Yes (non-safety needle) | Different.Bench,Biocompatibility, andSterilizationtestingconducted tosupportchange. |
| Syringe Volumes | 3 mL | 1 mL and 3 mL | Same |
| Needle Gauge Size | 22-25G | 22-25G | Same |
| Component Materials | |||
| Barrel Material | Radiation grade polypropylene | Radiation grade polypropylene | Same |
| SUBJECT DEVICE: | PREDICATE DEVICE: | COMPARISON | |
| BD Preset™ Syringe & BD A- | BD Preset™ & BD A-Line™ | ||
| Line™ Syringe | Blood Collection Syringe | ||
| Plunger Rod Material | Radiation grade polypropylene | Radiation grade polypropylene | Same. |
| Stopper Material(Pre-attached toplunger) | BD Preset™: Syntheticelastomer and venting mediaBD A-Line™:Syntheticelastomer | BD Preset™: syntheticelastomer and venting mediaBD A-Line™ syntheticelastomer | Same |
| Anticoagulant | Calcium balanced LithiumHeparin | Calcium balanced LithiumHeparin | Same |
| Barrel Printing | Black InkPolypropylene, Green colorant | Black InkPolypropylene (Translucent) | Same |
| Tip Cap | Different.Bench andBiocompatibilityevaluationsconducted tovalidatechange. | ||
| Biocompatibility | |||
| Biocompatibility | Passed ISO 10993 testing; | Passed ISO 10993 testing; | Same |
| Sterilization | Gamma (SAL 10-6) | Gamma (SAL 10-6) | Same |
| Shelf Life | 2 years | 2 years | Same |
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Performance Data
BD performed the following bench, biocompatibility, and sterilization testing to support the modifications of the BD Preset™ Syringe & BD A-Line™ Syringe. The results of these analyses demonstrate that the BD Preset™ Syringe & BD A-Line™ Syringe performed in an equivalent manner to the predicate device.
- Bench Performance .
- o Tip cap leak, Shield Activation Force, Shield Unlocking Force, Shield Removal, Plunger Separation Force, Plunger Activation Force, Leak Past Stopper, Needle Cannula Pull Out Force, Ship and Leak, Heparin Activity
Material Biocompatibility Performance ●
- o Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Color Migration, Extractables and Leachables
Sterilization Performance ●
- Requalification of sterilization validation
- . Compliance to Standards
- o ISO 10993-1: 2009/2018, ISO 10993-4: 2017; ISO 10993-5: 2009, ISO 10993-10: 2010, ISO 10993-11: 2017, ISO 10993-18: 2020, USP 42-NF37:2019 <87>, USP 42-NF37:2019 <88>, USP 42-NF37:2019 <151>,ASTM F2148-18, ISO 11137-1: 2006, ISO 11137-2: 2013, ISO 11137-3: 2017, ISO 11737-1: 2018, ISO 11737-2: 2019, ASTM D4169-16, ISO 15223-1
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In all instances, the BD Preset™ Syringe & BD A-Line™ Syringe functioned as intended and results demonstrated acceptable performance for the subject device.
Conclusion
The BD Preset™ Syringe & BD A-Line™ Syringe is as safe and effective as its predicate device. The BD Preset™ Syringe & BD A-Line™ Syringe has the same intended uses and similar technological characteristics, and principles of operation as its predicate device. The technological differences between the BD Preset™ Syringe & BD A-Line™ Syringe and its predicate device raise no new issues of safety or effectiveness. Bench, Biocompatibility, and Sterilization performance data demonstrate that the BD Preset™ Syringe & BD A-Line™ Syringe is as safe and effective as the predicate device. Thus, the BD Preset™ Syringe & BD A-Line™ Syringe is substantially equivalent to the predicate device.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.