(87 days)
Not Found
No
The device description and performance studies focus on mechanical features and physical properties, with no mention of AI or ML.
No.
The device is primarily intended for obtaining blood specimens and short-term, single infusions, both of which are diagnostic/sampling or temporary uses, not long-term treatment.
No
This device is a blood collection set and explicitly states its purpose is "to obtain blood specimens from patients." While the collected blood may be used for diagnostic purposes, the device itself is not performing a diagnostic function; it is a tool for specimen collection.
No
The device description clearly outlines physical components such as stainless steel cannulas, springs, hubs, wings, tubing, and connectors. The performance studies also focus on physical characteristics and functionality of these hardware components.
Based on the provided text, the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "venipuncture to obtain blood specimens from patients" and "short-term, single infusions." This describes a device used for collecting biological samples from the body, not for performing tests on those samples outside the body.
- Device Description: The description focuses on the physical components and mechanism for blood collection and safety features. It does not mention any components or functions related to analyzing or testing the collected blood.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely the collection of the specimen.
Therefore, the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a blood collection device, not an IVD.
N/A
Intended Use / Indications for Use
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multiple sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or 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 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 (comma separated list FDA assigned to the subject device)
JKA, FPA
Device Description
The BD Vacutainer® Push Button Blood Collection Set has two models. One is a steel winged blood collection set with flexible tubing, female luer connector, with an integrated male luer adapter which connects to a Vacutainer® Brand Needle Holder and is intended to be used with blood collection tubes. The other model is sold identical except without the male luer adapter. This model allows the clinician to obtain blood sampling with a syringe, if necessary, or can be used for short-term, single infusions. The device is not to be left in place and remain under the supervision of a clinician.
The BD Vacutainer® Push Button Blood Collection Set also contains a sharps injury prevention feature. The wing set is designed with an active retraction method. When the button is actively depressed, the needle fully retracts and is enclosed and locked within the barrel of the device. The retraction of the intravenous (IV) end of the needle is designed to protect users from an accidental needle sticks.
The BD Vacutainer® Push Button Blood Collection Set consists of:
- Stainless steel cannula (Intravenous end and Non-patient end of cannula)
- Stainless steel spring
- Hub. front and rear barrel
- Wings (color coded according to needle gauge)
- Tubing
- Female luer connector and an optional male luer adapter
- Intravenous (IV) needle protector (covers the needle before use)
- Luer Cap (provided if there is no luer adapter attached)
The intravenous needle of the blood collection set is bonded to one end of the hub. The tubing of the blood collection set is bonded to the other end of the hub and the female luer connector. A spring is assembled over the needle protector and onto the front of the hub. Once the sample is collected the user will depress the button that projects through the barrel. As soon as the button is depressed, the needle assembly moves using spring energy. In this retracted (locked) position, the IV point of the needle is fully contained within the body of the device. This will prevent the needle from coming out of the front barrel once it has retracted as well as preventing accidental overriding of the safety feature.
The optional male luer adapter contains threads for attachment to a Vacutainer® Brand Needle Holder, and a non-patient cannula for puncture of evacuated blood collection tube stoppers. The non-patient end (NP) of the cannula of the luer adapter has a sleeve that recovers over the cannula to stop blood flow during collection of multiple tubes.
The purpose of this Special 510(k) is to expand the needle range to include the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set design with ultra thin wall cannula and a five bevel point. The intended use for the modified device remains the same as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venipuncture site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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 has performed the following design verification testing based on the risk analysis conducted and the results of these tests demonstrate that the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set performed in an equivalent manner to the predicate device.
Performance Characteristic and Acceptance Criteria:
- Tubing diameters 21G, 23G and 25G: Tubing dimensions meet OD and ID requirement. Tested in accordance to ISO 9626, section 8, Dimensions, and to VS10362 BD requirements for Ultra thin wall cannula
- Retraction and Lockout: Equivalence to predicate device
- Flow Rate: Equivalence to predicate device
- IV Cannula Removal Force: Equivalence to predicate device
- Leak Testing: Equivalence to predicate device
- Hemolysis: Equivalence to predicate device
- Resistance to breakage: Tested in accordance to ISO 9626, section 10, resistance to breakage, annex D, and to VS10362 BD requirements for Ultra thin wall cannula
- 90° Penetration Testing/Bevel Sharpness: Per BD Test Method TP700279
- 20° Penetration Testing: Equivalence to predicate device
The results of the design verification testing demonstrate that the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set performs as intended and performs as well as the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Becton, Dickinson and Company Mr. Pasquale Amato Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K153309
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: II Product Code: JKA, FPA Dated: December 16, 2015 Received: January 11, 2016
Dear Mr. Amato:
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. 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.
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number (if known)
K153309 | Indications for Use |
| 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, multiple sampie, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or 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 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) | |
| 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 | |
| "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 (8/14) | Page 1 of 1 |
| PSC Publishing Services (301) 443-6740 EF | |
.
3
510(K) SUMMARY K153309
Submitted Bv: 1.
Pasquale Amato Staff Regulatory Affairs Specialist
Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417
Phone: 201-847- 4513 Email: Pasquale Amato@BD.com
Date Prepared: February 05, 2016
-
- Device:
T
- Device:
| Trade Name: | BD Vacutainer® UltraTouch™ Push Button Blood
Collection Set | |
|----------------------|----------------------------------------------------------------|--|
| Common Names: | Blood Collection Set | |
| Classification Name: | Blood Specimen Collection Device | |
| Classification: | Class II, 21 CFR 862.1675 | |
| Product Code: | IKA and FPA | |
Predicate Device: 3.
BD Vacutainer® Push Button Blood Collection Set - K030573 Manufactured by: Becton, Dickinson and Company
4. Device Description:
The BD Vacutainer® Push Button Blood Collection Set has two models. One is a steel winged blood collection set with flexible tubing, female luer connector, with an integrated male luer adapter which connects to a Vacutainer® Brand Needle Holder and is intended to be used with blood collection tubes. The other model is sold identical except without the male luer adapter. This model allows the clinician to obtain blood sampling with a syringe, if necessary, or can be used for short-term, single infusions. The device is not to be left in place and remain under the supervision of a clinician.
4
The BD Vacutainer® Push Button Blood Collection Set also contains a sharps injury prevention feature. The wing set is designed with an active retraction method. When the button is actively depressed, the needle fully retracts and is enclosed and locked within the barrel of the device. The retraction of the intravenous (IV) end of the needle is designed to protect users from an accidental needle sticks.
The BD Vacutainer® Push Button Blood Collection Set consists of:
-
- Stainless steel cannula (Intravenous end and Non-patient end of cannula)
-
- Stainless steel spring
-
- Hub. front and rear barrel
-
- Wings (color coded according to needle gauge)
- や Tubing
-
- Female luer connector and an optional male luer adapter
-
- Intravenous (IV) needle protector (covers the needle before use)
- & Luer Cap (provided if there is no luer adapter attached)
The intravenous needle of the blood collection set is bonded to one end of the hub. The tubing of the blood collection set is bonded to the other end of the hub and the female luer connector. A spring is assembled over the needle protector and onto the front of the hub. Once the sample is collected the user will depress the button that projects through the barrel. As soon as the button is depressed, the needle assembly moves using spring energy. In this retracted (locked) position, the IV point of the needle is fully contained within the body of the device. This will prevent the needle from coming out of the front barrel once it has retracted as well as preventing accidental overriding of the safety feature.
The optional male luer adapter contains threads for attachment to a Vacutainer® Brand Needle Holder, and a non-patient cannula for puncture of evacuated blood collection tube stoppers. The non-patient end (NP) of the cannula of the luer adapter has a sleeve that recovers over the cannula to stop blood flow during collection of multiple tubes.
The purpose of this Special 510(k) is to expand the needle range to include the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set design with ultra thin wall cannula and a five bevel point. The intended use for the modified device remains the same as the predicate device.
ર. Indications for Use:
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multiple sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without
5
the male adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or 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 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.
Technological Characteristics: 6.
The subject BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is equivalent to that of the predicate BD Vacutainer® Push Button Blood Collection Set in intended use, materials and performance characteristics. The Indications for Use are not identical; however, the intended use remains the same for blood collection/sampling.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| BD Vacutainer® UltraTouch™ Push | ||
| Button Blood Collection Set, 21G, 23G | ||
| and 25G | BD Vacutainer® Push Button | |
| Blood Collection Set 21G, 23G | ||
| and 25G (K030573) | ||
| Indications for Use | The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is a sterile, multiple sample, single-use fixed winged blood collection set intended for venipuncture to obtain blood specimens from patients. When used without the male adapter, the device allows the clinician to obtain blood sampling to the female hub with a syringe, if necessary, or 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 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. | The BD Vacutainer® Push Button Blood Collection Set is a sterile, multiple-sample, single-use winged blood collection set intended for venipuncture to obtain blood specimens from patients. The BD Vacutainer® UtraTouch™ Push Button Blood Collection Set is also indicated for the intravenous administration of fluids. It may be used for any patient population with consideration given to patient size and appropriateness for the solution being infused and duration of therapy.
The recommended use of the device is to activate the needle 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. |
| Needle Diameter OD | 21G, 23G and 25G | same |
| Needle Diameter ID | Ultra Thin Wall | Thin Wall |
| Needle Point | 5 bevel | 3 bevel |
| Needle Length | 3/4in | same |
| Wing | Polyolefin | same |
| Hub | Polypropylene | same |
| Button Ink | UV curable Ink | same |
| Front Barrel | Polypropylene | same |
| Rear Barrel | Acrylic | same |
| Rear Barrel Lubricant | Silicone | same |
| Rear Barrel Lubricant | Isopropyl Alcohol | same |
| Diluent | | |
| Spring | Stainless Steel 302 | same |
| IV Protector (Cannula Protector) | Polyethylene | same |
| IV Cannula/NP Cannula | Stainless Steel 304 | same |
| Tubing | PVC | same |
| Cannula Lubricant | Silicone | same |
| Cannula Adhesive | UV cured adhesive | same |
| Hub-Tubing Adhesive | UV cured adhesive | same |
| Female Luer Connector | ABS | same |
| Luer Adapter Hub | Polypropylene | same |
| NP Sleeve | Synthetic Isoprene Rubber | same |
| Luer Adhesive | Heat Curing Epoxy | same |
| Luer Cannula Lubricant | Medical Grade Silicones | same |
| Luer Cap | Polypropylene | same |
| Top Web | Paper | same |
| Blister | PETG Copolyester | same |
| Materials - comply with ISO 10993-1 | Yes | same |
| Non-pyrogenic | Yes | same |
| Non-toxic | Yes | same |
| Sterile | Yes | same |
| SAL 10-6 | Yes | same |
| Sterilization | Gamma | same |
| Shelf Life | 2 years | same |
6
7. Performance:
BD has performed the following design verification testing based on the risk analysis conducted and the results of these tests demonstrate that the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set performed in an equivalent manner to the predicate device.
7
| Performance Characteristic | Acceptance Criteria |
|---|---|
| Tubing diameters 21G, 23G and | |
| 25G | Tubing dimensions meet OD and ID |
| requirement. Tested in accordance to ISO | |
| 9626, section 8, Dimensions, and to VS10362 | |
| BD requirements for Ultra thin wall cannula | |
| Retraction and Lockout | Equivalence to predicate device |
| Flow Rate | Equivalence to predicate device |
| IV Cannula Removal Force | Equivalence to predicate device |
| Leak Testing | Equivalence to predicate device |
| Hemolysis | Equivalence to predicate device |
| Resistance to breakage | Tested in accordance to ISO 9626, section 10, |
| resistance to breakage, annex D, and to | |
| VS10362 BD requirements for Ultra thin wall | |
| cannula | |
| 90° Penetration Testing/Bevel | |
| Sharpness | Per BD Test Method TP700279 |
| 20° Penetration Testing | Equivalence to predicate device |
Substantial Equivalence: 8.
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set is substantially equivalent to the predicate device in intended use, principles of operation, technology, design, materials and performance.
9. Conclusion:
The BD Vacutainer® UltraTouch™ Push Button Blood Collection Set has been verified to meet the established performance criteria above. The results of the design verification testing demonstrate that the BD Vacutainer® UltraTouch™ Push Button Blood Collection Set performs as intended and performs as well as the legally marketed predicate device.