(264 days)
Not Found
No
The device description focuses on mechanical features and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for infusing fluids and blood components, not for treating a disease or condition itself.
No
The device is an intravenous catheter used for infusing fluids and blood components, and its description focuses on its physical characteristics and safety mechanism, not on diagnosing medical conditions.
No
The device description clearly describes a physical, over-the-needle catheter made of radiopaque polyurethane with a passive safety mechanism. It is a hardware device.
Based on the provided information, the Nipro SafeTouch IV Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for insertion into the patient's vascular system for the infusion of fluids and/or blood components. This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a physical device (catheter) designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. The Nipro SafeTouch IV Catheter is used inside the body for direct patient care.
N/A
Intended Use / Indications for Use
The Nipro SafeTouch IV Catheter is a passive anti-needle stick intra-vascular catheter that is inserted into the patient's vascular system for short term use for the infusion of fluids, and/or blood components. 16-24 gauge catheters may be used with power injectors for which the maximum pressure setting is 300psi
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
Nipro SafeTouch IV Catheter consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety mechanism that will engage upon removal from the patient in order to prevent accidental needlestick injuries. The device is available in gauges 16-24 and in catheter lengths of ¾" – 2". It is also available with or without wings on the hub. Gauges are color coded for easy differentiation. Nipro SafeTouch IV Catheter is sterilized by Ethylene Oxide gas (EtO). It is packaged in a peel blister that ensures the sterility of the device until package is opened and labeled for single use only. A sleeve of SafeTouch Cath contains 5 units of blister packages. An inner box contains 10 sleeves (50 units). An outer box contains 40 inner boxes (3000 units). Its shelf life period is 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
Non-clinical tests submitted are for dimensional and performance, sterilization and biocompatibility:
-
- Disengagement force between components (internal test method)
- Penetration force (internal test method) 2.
-
- Air leakage (internal test method)
-
- Flow rate (internal test method)
-
- Safety mechanism performance (simulated clinical study)
- Package integrity/microbial barrier (ISO 11607-2) 6.
-
- Chemical testing / acid, alkalinity and extractable metals (ISO 7864:1993)
- Corrosion resistance (ISO 10555-1:1995) 8.
- Sterilization validation (ISO 11135-1:2007, ISO 11135-2:2008) 9.
-
- Eto residuals (ISO 10993-7)
-
- Transportation tests (ASTM-d4169-09)
-
- Biocompatibility (ISO 10993)
- a. Cytotoxicity: MEM Elution
- b. Sensitization: Kligman Maximization
- ﻥ Intracutaneous Irritation
- d. Acute Systemic Toxicity: Systemic Injection
- e. Rabbit Pyrogen
- f. Hemolysis –Rabbit Blood – direct and indirect contact
- Complement Activation SC5b9 g.
- h. Complement Activation - СЗа
- i. Dog Thrombogenicity
- j. ASTM Partial Thromboplastin Time
- Genotoxicity: Bacterial Reverse Mutation Study k.
-
- Mouse Peripheral Blood Micronucleus Study
- m. Two Week Rat Study, Repeated Parenteral Administration of Two Extracts
- n. Genotoxicity: Mouse Lymphoma Assay
- o. ISO Muscle Implantation Study 2 Week
- p. LAL testing
- q. Particulate matter testing
-
- Pyrogen testing (USP 35-NF30:2012, )
-
- Shelf-life testing (ASTM F1980-07)
All of the above tests were performed within the specifications of the standards listed above.
A simulated clinical test was performed to evaluate the effectiveness of the safety mechanism. This test passed with zero failures.
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
§ 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2017
Nipro Medical Corporation % Jessica Oswald-McLeod Director, Quality Assurance & Regulatory Affairs 3150 NW 107th Ave. Miami, Florida 33172
Re: K161681
Trade/Device Name: Nipro SafeTouch IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: June 14, 2016 Received: June 17, 2016
Dear Jessica Oswald-McLeod:
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.
Lori A. Wiggins -S
for Tina Kiang, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
K161681
Device Name Nipro SafeTouch IV Catheter
Indications for Use (Describe)
The Nipro SafeTouch IV Catheter is a passive anti-needle stick intra-vascular catheter that is inserted into the patient's vascular system for short term use for the infusion of fluids, and/or blood components. 16-24 gauge catheters may be used with power injectors for which the maximum pressure setting is 300psi
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)
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)
3
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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."
4
510(k) Summary: Nipro SafeTouch IV Catheter K161681
807.92(a)(1)
Applicant:
| Applicant: | Nipro Medical Corporation
3150 NW 107th Ave.
Miami FL 33172
Tel: 305-599-7174 |
|---------------------|----------------------------------------------------------------------------------------|
| Establishment Reg.: | 1056186 |
| Contact Person: | Jessica Oswald-McLeod
Director, Quality Assurance & Regulatory Affairs |
Date of summary preparation: March 7, 2017
807.92(a)(2)
Trade Name: Nipro SafeTouch IV Catheter Common Name: Safety IV Catheter Classification Name: catheter, intravascular Regulation Number: 21 CFR 880.5200 Panel: 80 Product Code: FOZ
807.92(a)(3)
Legally marketed substantial equivalent device: B Braun Introcan Safety IV Cath (K020785)
807.92(a)(4)
Description of device:
Nipro SafeTouch IV Catheter consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety mechanism that will engage upon removal from the patient in order to prevent accidental needlestick injuries. The device is available in gauges 16-24 and in catheter lengths of ¾" – 2". It is also available with or without wings on the hub. Gauges are color coded for easy differentiation. Nipro SafeTouch IV Catheter is sterilized by Ethylene Oxide gas (EtO). It is packaged in a peel blister that ensures the sterility of the device until package is opened and labeled for single use only. A sleeve of SafeTouch Cath contains 5 units of blister packages. An inner box contains 10 sleeves (50 units). An outer box contains 40 inner boxes (3000 units). Its shelf life period is 5 years.
807.92(a)(5)
Indications for Use:
The Nipro SafeTouch IV Catheter is a passive anti-needle stick intra-vascular catheter that is inserted into the patient's vascular system for short term use for the infusion of fluids, and/or blood components. 16-24 gauge catheters may be used with power injectors for which the maximum pressure setting is 300psi
5
807.92(a)(6)
Comparison of technological characteristics:
The catheter is substantially equivalent to the predicate device in the following technological characteristics:
| Element of Comparison | Nipro SafeTouch IV Catheter | Predicate |
|---|---|---|
| Materials | PUR, PP, PC, Stainless Steel | Available in two materials: |
- FEP, PP, ABS, chrome-
nickel steel - PUR, PP, ABS, chrome-
nickel steel |
| Design: Operational mode | Mechanical - Manually
operated IV catheter with a
passive safety mechanism | Same |
| Design: Physical
characteristics | Safety IV Catheter, with
passive anti-stick safety
mechanism. | Same |
| Design: Device
Configurations | Available in both winged and non-winged Needle gauges 16-24 catheter lengths of ¾" – 2" Color coded hubs for easy identification distal end: Luer connector proximal end: Cannula and catheter | Same |
| Intended Use | The Nipro SafeTouch IV
Catheter is a passive anti-
needle stick intra-vascular
catheter that is inserted into
the patient's vascular system
for short term use for the
infusion of fluids, and/or
blood components. 16-24
gauge catheters may be used
with power injectors for
which the maximum pressure
setting is 300psi | Passive anti-needle stick
device for venous or arterial
access for the infusion of
fluids, drugs, and/or blood
components. 14-22 gauge
catheters may be used with
power injectors for which
the maximum pressure
setting is 300psi |
| Sterilization and Expiry
dating | Method: Ethylene Oxide
Shelf-life: 5 years | Same |
| Energy Source | NA | NA |
Table 4: Comparison of technological characteristics
6
Non-clinical tests submitted are for dimensional and performance, sterilization and biocompatibility:
-
- Disengagement force between components (internal test method)
- Penetration force (internal test method) 2.
-
- Air leakage (internal test method)
-
- Flow rate (internal test method)
-
- Safety mechanism performance (simulated clinical study)
- Package integrity/microbial barrier (ISO 11607-2) 6.
-
- Chemical testing / acid, alkalinity and extractable metals (ISO 7864:1993)
- Corrosion resistance (ISO 10555-1:1995) 8.
- Sterilization validation (ISO 11135-1:2007, ISO 11135-2:2008) 9.
-
- Eto residuals (ISO 10993-7)
-
- Transportation tests (ASTM-d4169-09)
-
- Biocompatibility (ISO 10993)
- a. Cytotoxicity: MEM Elution
- b. Sensitization: Kligman Maximization
- ﻥ Intracutaneous Irritation
- d. Acute Systemic Toxicity: Systemic Injection
- e. Rabbit Pyrogen
- f. Hemolysis –Rabbit Blood – direct and indirect contact
- Complement Activation SC5b9 g.
- h. Complement Activation - СЗа
- i. Dog Thrombogenicity
- j. ASTM Partial Thromboplastin Time
- Genotoxicity: Bacterial Reverse Mutation Study k.
-
- Mouse Peripheral Blood Micronucleus Study
- m. Two Week Rat Study, Repeated Parenteral Administration of Two Extracts
- n. Genotoxicity: Mouse Lymphoma Assay
- o. ISO Muscle Implantation Study 2 Week
- p. LAL testing
- q. Particulate matter testing
-
- Pyrogen testing (USP 35-NF30:2012, )
-
- Shelf-life testing (ASTM F1980-07)
All of the above tests were performed within the specifications of the standards listed above.
807.92(b)(2)
Clinical tests:
This submission does not warrant any clinical testing, therefore no clinical testing performed for or provided in this submission.
A simulated clinical test was performed to evaluate the effectiveness of the safety mechanism. This test passed with zero failures.
807.92(b)(3)
Conclusions drawn from non-clinical and clinical tests:
The results of the performance testing and the comparison of technological characteristics with the predicate device demonstrate that the Nipro SafeTouch IV Catheter performs equivalent to the predicate device when used as intended.