(161 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
Explanation: The device is primarily intended for obtaining blood specimens and short-term, single infusions, not for treating a disease or condition.
No
Explanation: This device is explicitly described as a "blood collection set" intended for "venipuncture to obtain blood specimens." Its purpose is to collect samples, not to analyze them or provide diagnostic information.
No
The device description clearly outlines physical components like needles, tubing, connectors, and a needle protector, indicating it is a hardware device.
Based on the provided text, the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is for venipuncture to obtain blood specimens from patients. While these specimens are used for in vitro diagnostic testing, the device itself is the tool for collecting the sample, not for performing the diagnostic test on the sample.
- Device Description: The description focuses on the physical components of a blood collection set (needles, tubing, connectors, holder). It does not describe any components or functions related to analyzing or testing the blood sample.
- Lack of IVD Characteristics: The text does not mention any features or processes related to:
- Analyzing biological samples in vitro.
- Detecting or measuring substances in the blood.
- Providing diagnostic information about a patient's health.
The device is a blood collection device, which is a tool used in the process of obtaining samples for IVD testing, but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients, including those patients with difficult vein access who may have small, fragile, and/or non-palpable veins, into evacuated blood collection tubes and/or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe, if necessary. The device can be used for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
Product codes
JKA, FPA
Device Description
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a winged blood collection set with flexible tubing, a female luer connector and a male luer adapter. The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set also contains a needle protector.
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set models available consist of a combination of different needle gauges (21G, 23G, 25G), tubing length (12-inch, 7 inch), and are available with or without a pre-attached holder.
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
trained healthcare professionals
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
The sponsor has determined that since the subject and predicate blood collection sets are the same, and the BD Vacutainer® Brand Holder is unchanged from clearance under K181730, new performance testing is not required. Specifically, because there has been no significant change to design, product materials, packaging materials, processing/assembly, packaging, or manufacturing that would affect device performance no new performance testing is provided in support of this submission.
Key Metrics
Not Found
Predicate Device(s)
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set (K153309)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration. The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
August 31, 2022
Becton, Dickinson and Company Katherine Lemus Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K212724
Trade/Device Name: BD Vacutainer UltraTouch Push Button Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FPA
Dear Katherine Lemus:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination for your device cleared on February 4, 2022. Specifically, FDA is updating this SE letter due to the clearance date not appearing on the original letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6029, payal.patel(@fda.hhs.gov.
Sincerely,
Pyd for
Payal Patel 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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Becton, Dickinson and Company Katherine Lemus Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K212724
Trade/Device Name: BD Vacutainer UltraTouch Push Button Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FPA Dated: December 29, 2021 Received: January 5, 2022
Dear Katherine Lemus:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
2
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,
Cuffley
Gang Peng for Payal Patel 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
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set
Indications for Use (Describe)
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended to be used by trained healthcare professionals for venipuncture to obtain blood specimens from patients, including those patients with difficult vein access who may have small, fragile, and/or non-palpable veins, into evacuated blood collection tubes and/or blood culture bottles. When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe, if necessary. The device can be used for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
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information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
4
510(K) SUMMARY K212724
Summary Preparation Date:
2/4/2022
Submitted by:
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417-1885
Phone: (201) 847-6800
Contact:
Katherine Kenner Lemus, MS, RAC-US Senior Regulatory Affairs Specialist email: Katherine.lemus@bd.com
Phone: (801) 541-9274 Work: (201) 847 6800:
Proprietary Names:
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set:
Common or Usual Names:
Blood Collection Set, IV Administration Set
Regulatory Information
Classification Name: Blood Collection Set, IV Administration Set Classification Regulation: 21 CFR §862.6175 and 880.5440 Regulatory Class: Class II Product Code: JKA, FPA
Predicate Device(s)
BD Vacutainer® UltraTouch™ Push Button Blood Collection Set (K153309)
Device Description
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a winged blood collection set with flexible tubing, a female luer connector and a male luer adapter. The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set also contains a needle protector.
5
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set models available consist of a combination of different needle gauges (21G, 23G, 25G), tubing length (12-inch, 7 inch), and are available with or without a pre-attached holder.
Indications For Use
The proposed indications for use, are similar to the predicate indications for use, except for the inclusion of both healthy patients with vascular anatomy and/or co-morbidities which may cause difficulty in locating a vein. Healthy patients and patients with these conditions often exhibit small, fragile, non-palpable veins, commonly referred to as difficult vein access (DVA). The addition of DVA in the revised indications for use statement does not significantly change the intended use as butterfly needles have historically been used on patients with small veins and similar statements were included for previous device iterations and were inadvertently removed in subsequent submissions. BD believes that the addition of specific reference to patients with DVA does not raise new questions of safety/effectiveness.
6
Substantial Equivalence1/Technical Comparison
The subject and predicate device are substantially equivalent as described in Table 2.
| Characteristic | Subject Device
BD Vacutainer® UltraTouch™
Push Button Blood Collection
Set | Predicate Device
BD Vacutainer® UltraTouch™
Push Button Blood Collection
Set
K153309 | Comparison |
|----------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Population | General use including patients
with difficult vein access (DVA) | General use | Different
Comment #1
Added specific
reference to patients
with DVA which is a
subset of 'General
Use' - no effect on
device safety or
effectiveness |
| Needle Diameter
OD | 21G, 23G and 25G | 21G, 23G and 25G | Same |
| Needle Diameter
ID | Ultra-Thin wall | Ultra-Thin wall | Same |
| Needle Point | 5 Bevel | 5 Bevel | Same |
| Needle Length | 3/4 inch | 3/4 inch | Same |
| Wing | Polyolefin | Polyolefin | Same |
| Hub | Polypropylene | Polypropylene | Same |
| Button Ink | UV Curable Ink | UV Curable Ink | Same |
| Front Barrel | Polypropylene | Polypropylene | Same |
| Rear Barrel | Acrylic | Acrylic | Same |
| Rear Barrel
Lubricant | Silicone | Silicone | Same |
| Rear Barrel
Lubricant Diluent | Isopropyl Alcohol | Isopropyl Alcohol | Same |
| Spring | Stainless Steel 302 | Stainless Steel 302 | Same |
| IV Protector
(Cannula
Protector) | Polyethylene | Polyethylene | Same |
| IV Cannula/NP
Cannula | Stainless Steel 304 | Stainless Steel 304 | Same |
| Tubing | Polyvinyl Chloride | Polyvinyl Chloride | Same |
Table 1: Substantial Equivalence Comparison
7
| Characteristic | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| BD Vacutainer® UltraTouch™ | |||
| Push Button Blood Collection | |||
| Set | BD Vacutainer® UltraTouch™ | ||
| Push Button Blood Collection | |||
| Set | |||
| K153309 | |||
| Cannula | |||
| Lubricant | Silicone | Silicone | Same |
| Cannula Adhesive | UV cured adhesive | UV cured adhesive | Same |
| Hub-Tubing | |||
| Adhesive | UV cured adhesive | UV cured adhesive | Same |
| Female Luer | |||
| Connectors | Acrylonitrile Butadiene Styrene | Acrylonitrile Butadiene Styrene | Same |
| Luer Adapter Hub | Polypropylene | Polypropylene | Same |
| NP Sleeve | Synthetic Isoprene Rubber | Synthetic Isoprene Rubber | Same |
| Luer Adhesive | Heat Curing Epoxy | Heat Curing Epoxy | Same |
| Luer Cannula | |||
| Lubricant | Medical Grade Silicone | Medical Grade Silicone | Same |
| Luer Cap | Polypropylene | Polypropylene | Same |
| Top Web | Paper | Paper | Same |
| Blister | Polyethylene terephthalate – | ||
| glycol modified | Polyethylene terephthalate – | ||
| glycol modified | Same | ||
| Pre-attached | |||
| holder | Polypropylene | N/A | Different |
| Comment #2 | |||
| 6 model numbers | |||
| were added to | |||
| include devices | |||
| assembled with the | |||
| legally marketed | |||
| holder pre-attached | |||
| for user | |||
| convenience. This | |||
| non-significant | |||
| change does not | |||
| affect safety or | |||
| effectiveness | |||
| Materials | Compliant with ISO 10993 | ||
| series | Compliant with ISO 10993 | ||
| series | Same | ||
| Non-pyrogenic | Yes | Yes | Same |
| Non-toxic | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterility | |||
| Assurance Level | |||
| (SAL) 10-6 | Yes | Yes | Same |
8
| Characteristic | Subject Device
BD Vacutainer® UltraTouch™
Push Button Blood Collection
Set | Predicate Device
BD Vacutainer® UltraTouch™
Push Button Blood Collection
Set
K153309 | Comparison |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization
Method | Gamma | Gamma | Same |
| Shelf Life | 2 years | 2 years | Same |
| Models | 367363
367364
367365
367391
367392
367393
368684
368685
368686
368687
368688
368689 | 367363
367364
367365
367391
367392
367393 | 6 model numbers
were added to
include devices
assembled with the
legally marketed
holder pre-attached
for user
convenience. This
non-significant
change does not
affect safety or
effectiveness |
Substantial Equivalence Discussion:
Comment #1
The subject device indicates that the intended population is for general use, including a subset of patients who may have difficult veins, whereas the predicate device population is general use. Both devices are used on all patient populations regardless of their vein status. Adding a reference to patients with difficult veins has no effect on clinical safety or effectiveness.
Comment #2
The subject device is available in models with and without a pre-attached holder. The predicate device is only available in models without the pre-attached holder and requires the user to add a holder in order to use the device for blood collection. Adding models with the pre-attached holder to the subject device is a user convenience and does not affect clinical safety or effectiveness.
Applicable Standards:
I. Performance Standards
ISO 594-1-1986 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
ISO 594-2-1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock fittings
9
EN ISO 23908:2013 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
EN ISO 14971:2012 Medical Devices - Application of risk management to medical devices
II. Sterilization, Package Integrity, Shipping and Shelf Life
EN ISO 11137-1:2015/A2:2019 Sterilization 15of health care products - Radiation Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
EN ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
EN ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
EN ISO 11737-2:2019 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F88 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
III. Biocompatibility Standards
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
10
EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of materials
Technical Performance Summarv
The sponsor has determined that since the subject and predicate blood collection sets are the same, and the BD Vacutainer® Brand Holder is unchanged from clearance under K181730, new performance testing is not required. Specifically, because there has been no significant change to design, product materials, packaging materials, processing/assembly, packaging, or manufacturing that would affect device performance no new performance testing is provided in support of this submission.
Conclusion
The technical performance characteristics of the subject device are unchanged. The clinical literature, BD's sponsored studies, and Investigator sponsored studies sufficiently support the determination that patients with Difficult Vein Access (DVA) is a subset of the current patient population for the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set. The risk profile of patients with DVA is not substantially different from that of the general patient population and is supported by the extensive clinical literature evidence presented under this submission. Based on information provided in this submission the proposed device is substantially equivalent to the predicate device.