(69 days)
Not Found
No
The document describes a prefilled syringe with Heparin Lock Flush Solution and a change to the stopper material. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is intended for "maintenance of patency of vascular access devices," which is a preventative measure to ensure proper function of medical equipment, thereby contributing to patient treatment and care.
No
Explanation: The device is a heparin lock flush solution intended for maintaining the patency of vascular access devices. Its purpose is to prevent clots and keep the device open, which is a therapeutic or maintenance function, not a diagnostic one.
No
The device description clearly outlines a physical syringe prefilled with a solution, and the submission focuses on a change to a physical component (the stopper material). There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "maintenance of patency of vascular access devices only." This is a therapeutic or maintenance function performed directly on the patient's vascular system, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a prefilled syringe containing a solution for flushing vascular access devices. This aligns with a medical device used for patient care, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical/chemical in maintaining the function of a medical device (the vascular access device) within the patient.
N/A
Intended Use / Indications for Use
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.
Product codes (comma separated list FDA assigned to the subject device)
NGT, NZW
Device Description
Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe (also referred to as BD PosiFlush" Heparin Lock Flush Syringe) is provided in either 10 or 100 Units/mL concentrations in 0.9% Sodium Chloride Injection, USP packaged in a plastic, disposable, single use syringe. The syringe is a three-piece, single use syringe with a 6% (luer) connector prefilled with Heparin Lock Flush Solution, and sealed with a tip cap. The BD PosiFlush"" Heparin Lock Flush Syringe is provided in a 3mL or 5mL size configuration. The BD PosiFlush™ Heparin Lock Flush Syringe is provided with a sterile fluid path, sterilized via moist heat. The solution is delivered through the vascular access device to maintain catheter patency and is not to be used for anticoagulation therapy.
The change described in this submission is to qualify a new stopper material used in the BD PosiFlush " Heparin Lock Flush Syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access devices
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)
Modifications to BD PosiFlush™ Heparin Lock Flush Syringe were evaluated using a risk management process. This risk assessment process was performed in accordance with ISO14971. The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility evaluation was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," June 16, 2016. The battery of testing included the following tests and assessments. Cytotoxicity (per ISO10993-5), Hemolysis (per ISO10993-4). Acute systemic toxicity (per ISO10993-11), Sub-Chronic Toxicity (Per ISO10993-11), Intracutaneous reactivity (per ISO10993-10), Ocular irritation (per ISO 10993-10), Partial thromboplastin Time (ISO10993-4). Sensitization (per ISO10993-10). Pvrogenicity (per ISO 10993-11), Genotoxicity (per ISO 10993-3) and Chemical extractable analysis (per ISO 10993-18).
Design Verification testing was also conducted to ensure the device met the predetermined acceptance criteria for the following tests; Container Closure Integrity, Break Loose/Break Out/Sustaining force, Stopper Separation, Leakage, Pump Force, Ship Test, Dead Space, Syringe Induced Reflux were performed to demonstrate that the subject device met predetermined acceptance criteria per BD's internal specification.
The BD PosiFlush™ Heparin Lock Flush Syringes have been verified to meet the established performance criteria above. The results of design verification testing demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device and demonstrated the same intended use, fundamental scientific technology and operating principles.
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
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
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, which is a symbol often associated with healthcare. The caduceus is composed of three abstract human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2017
Becton Dickinson And Company Aakash Jain Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07045
Re: K163591
Trade/Device Name: BD Posiflush Heparin Lock Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: December 16, 2016 Received: December 20, 2016
Dear Aakash Jain:
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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Susan Runno DDS, MA
For Tina Kiang Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe
Indications for Use (Describe)
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.
| 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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3
Special 510(k) Summary
| Submitted By: | Aakash Jain
Senior Regulatory Affairs Specialist
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Phone: (201)847-5879
Fax: (201)847-5307 | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 8, 2017 | |
| Subject Devices: | Trade Name: | Heparin Lock Flush Solution, USP-
BD PosiFlush™ Heparin Lock Flush Syringe |
| | Common Name: | Heparin, Vascular Access Flush |
| | Classification: | Class II, 21 CFR §880.5200 |
| | Product Code: | NZW |
| Predicate Devices: | Trade Name: | Heparin Lock Flush Solution, USP-
BD PosiFlush™ Heparin Lock Flush Syringe |
| | 510(k) Reference: | K090680 |
| | Common Name: | Heparin, Vascular Access Flush |
| | Classification: | Class II, 21 CFR §880.5200 |
| | Product Code: | NZW |
| Device
Characteristics | Subject Device
BD PosiFlush™ Heparin Lock Flush
Syringe
(K163591) | Predicate Device
BD PosiFlush™ Heparin Lock Flush
Syringe
(K090680) |
| Manufacturer | Becton, Dickinson and Company | Becton, Dickinson and Company |
| Intended Use | The Heparin Lock Flush Solution,
USP, BD PosiFlush™ Heparin Lock
Flush Syringes are intended for
maintenance of patency of vascular
access devices only. | The Heparin Lock Flush Solution,
USP, BD PosiFlush™ Heparin Lock
Flush Syringes are intended for
maintenance of patency of vascular
access devices only. |
| Operating
Principle | The BD PosiFlush™ Heparin Lock
Flush Syringe is a three-piece,
sterile, single use syringe with a 6%
(Luer) connector pre-filled with
heparin sodium, USP in either
10U/mL or 100U/mL concentration
0.9% Sodium Chloride Injection,
USP, and sealed with a tip cap. | The BD PosiFlush™ Heparin Lock
Flush Syringe is a three-piece, sterile,
single use syringe with a 6% (Luer)
connector pre-filled with heparin
sodium, USP in either 10U/mL or
100U/mL concentration 0.9%
Sodium Chloride Injection, USP, and
sealed with a tip cap. |
| Materials | Barrel: Polypropylene
Plunger Rod: Polypropylene
Tip Cap: Polypropylene w/ Blue (10
units/mL) or Yellow (100 units/mL)
Colorant
Stopper Lubricant: Silicone
Stopper Material: Bromobutyl
Rubber | Barrel: Polypropylene
Plunger Rod: Polypropylene
Tip Cap: Polypropylene w/ Blue (10
units/mL) or Yellow (100 units/mL)
Colorant
Stopper Lubricant: Silicone
Stopper Material: Styrene-butadiene
Rubber |
| Packaging | Flow wrap
Shelf Carton
Case Carton | Flow wrap
Shelf Carton
Case Carton |
| Specification | Provided in 3 mL and 5 mL in either
10U/mL or 100U/mL
configurations. All sizes utilize a
consistent 10 mL syringe barrel
diameter. | Provided in 3 mL and 5 mL in either
10U/mL or 100U/mL configurations.
All sizes utilize a consistent 10 mL
syringe barrel diameter. |
| Device
Characteristics | Subject Device | Predicate Device |
| | BD PosiFlush™ Heparin Lock Flush
Syringe
(K163591) | BD PosiFlush™ Heparin Lock Flush
Syringe
(K090680) |
| Shelf Life | 10U/mL- 18 Months
100U/mL- 24 Months | 10U/mL- 18 Months
100U/mL- 24 Months |
| Sterilization | Per ISO 17665 | Per ISO 17665 |
| SAL Level | SAL 10-6 | SAL 10-6 |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 |
Device Description
Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe (also referred to as BD PosiFlush" Heparin Lock Flush Syringe) is provided in either 10 or 100 Units/mL concentrations in 0.9% Sodium Chloride Injection, USP packaged in a plastic, disposable, single use syringe. The syringe is a three-piece, single use syringe with a 6% (luer) connector prefilled with Heparin Lock Flush Solution, and sealed with a tip cap. The BD PosiFlush"" Heparin Lock Flush Syringe is provided in a 3mL or 5mL size configuration. The BD PosiFlush™ Heparin Lock Flush Syringe is provided with a sterile fluid path, sterilized via moist heat. The solution is delivered through the vascular access device to maintain catheter patency and is not to be used for anticoagulation therapy.
The change described in this submission is to qualify a new stopper material used in the BD PosiFlush " Heparin Lock Flush Syringe.
Intended Use
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe are intended for maintenance of patency of vascular access devices only.
4
Technological Characteristics
The subject BD PosiFlush™ Heparin Lock Flush Syringe are equivalent to that of the predicate BD PosiFlush™ Heparin Lock Flush Syringe in intended use, fundamental scientific technology, operating principles, product design, and performance characteristics.
5
Performance Data
Modifications to BD PosiFlush™ Heparin Lock Flush Syringe were evaluated using a risk management process. This risk assessment process was performed in accordance with ISO14971. The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility evaluation was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," June 16, 2016. The battery of testing included the following tests and assessments. Cytotoxicity (per ISO10993-5), Hemolysis (per ISO10993-4). Acute systemic toxicity (per ISO10993-11), Sub-Chronic Toxicity (Per ISO10993-11), Intracutaneous reactivity (per ISO10993-10), Ocular irritation (per ISO 10993-10), Partial thromboplastin Time (ISO10993-4). Sensitization (per ISO10993-10). Pvrogenicity (per ISO 10993-11), Genotoxicity (per ISO 10993-3) and Chemical extractable analysis (per ISO 10993-18).
Design Verification testing was also conducted to ensure the device met the predetermined acceptance criteria for the following tests; Container Closure Integrity, Break Loose/Break Out/Sustaining force, Stopper Separation, Leakage, Pump Force, Ship Test, Dead Space, Syringe Induced Reflux were performed to demonstrate that the subject device met predetermined acceptance criteria per BD's internal specification.
Substantial Equivalence
The BD PosiFlush™ Heparin Lock Flush Syringes have been verified to meet the established performance criteria above. The results of design verification testing demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device and demonstrated the same intended use, fundamental scientific technology and operating principles.
Conclusion
The subject BD PosiFlush™ Heparin Lock Flush Syringes are substantially equivalent to the legally marketed predicate device, BD PosiFlush™ Heparin Lock Flush Syringes (K090680)