(112 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical safety features of a winged infusion set, with no mention of AI or ML technology.
No.
The device's primary function is for administering fluids and sampling blood, and its safety mechanism is to prevent needlesticks, which are functional aspects rather than therapeutic.
No
The device is an infusion set used to administer fluids or sample blood, not to diagnose a medical condition. Its function is to facilitate the direct introduction or removal of substances from the vascular system.
No
The device description clearly outlines physical components like a winged needle, tubing, and luer connector, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for insertion into a patient's vascular system to administer fluids intravenously or sample blood. This is a direct interaction with the patient's body for therapeutic or diagnostic sample collection purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details a needle, tubing, and luer connector, all components used for accessing the vascular system. There is no mention of reagents, test strips, or other components typically associated with in vitro testing.
- Lack of IVD Indicators: The document does not mention any of the keywords or concepts commonly associated with IVD devices, such as:
- Testing of biological samples (other than collection)
- Analysis of analytes
- Diagnostic assays
- Laboratory use
The device is clearly intended for direct patient care and sample collection, which falls under the category of medical devices, but not specifically in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. The tubing material is DEHP-free PVC and the filter has been added to prevent the flow of particulate matter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vascular system
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)
Performance testing was conducted to verify that the device is safe and effective for its intended use. Those tests include appearance, dimensional, package integrity testing and functional testing to include: Penetration force (puncture resistance testing), Pull force of connections, Safety Mechanism Deactivation force, Needle Clogging Test, Leakage of product, Luer Cap Separation, Connector Taper Leakage, Internal/external surface of cannula, Cannula Elasticity, Cannula Bending Strength and Product Air Tightness. The results and conclusions of these tests are included in this submission.
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 Nipro Medical Corporation. The logo consists of a stylized, abstract symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. Below "NIPRO" is the text "MEDICAL CORPORATION" in a smaller, sans-serif font. The entire logo is black and white.
3150 NW 107th Avenue Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621
MAR 1 2 2012
510(k) Summary SafeTouch PSV winged Infusion Set with/without filter
807.92(a)(1)
| Applicant: | |
|---|---|
| Establishment Reg.: |
Nipro Medical Corporation 1056186
Contact Person:
Jessica Oswald Regulatory Affairs Specialist
Date of summary preparation: November 4, 2011
807.92(a)(2)
Trade Name: SafeTouch PSV winged Infusion Set with/without filter Common Name: Safety Scalp Vein Set Classification Name: catheter,intravascular,therapeutic,short-term less than 30 days Regulation Number: 21 CFR 880.5200 Panel: 80 Product Code: FOZ
807.92(a)(3)
Legally marketed substantial equivalent device: K011297 - NIPRO SafeTouch Scalp Vein Set and Blood Collection Needle
807.92(a)(4)
Description of device:
The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. The tubing material is DEHP-free PVC and the filter has been added to prevent the flow of particulate matter.
807.92(a)(5)
Indications for Use:
This device is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.
807.92(a){6)
Comparison of technological characteristics:
The Nipro SafeTouch Scalp Vein Set with/without filter is identical to the predicate device, in terms of:
- basic scientific technology, .
- . design,
- . Intended Use and
- . Operational technique.
1
The differences between the proposed device and the predicate device are:
- Physical characteristics/components addition of the particulate matter filter .
- Material Characteristics change to DEHP-Free tubing .
807.92(b)(1)
Non-clinical tests submitted:
Performance testing was conducted to verify that the device is safe and effective for its intended use. Those tests include appearance, dimensional, package integrity testing and functional testing to include: Penetration force (puncture resistance testing), Pull force of connections, Safety Mechanism Deactivation force, Needle Clogging Test, Leakage of product, Luer Cap Separation, Connector Taper Leakage, Internal/external surface of cannula, Cannula Elasticity, Cannula Bending Strength and Product Air Tightness. The results and conclusions of these tests are included in this submission.
807.92(b)(2)
Clinical tests submitted:
Substantial equivalence was proven through bench testing. No clinical testing was required or performed in support of this 510k submission.
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 SafeTouch PSV performs equivalent to the predicate device and is safe and effective when used as intended.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is 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 an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jessica Oswald Regulatory Affairs Specialist Nipro Medical Corporation 3150 NW 107th Avenue Miami, Florida 33172
MAR 1 2 2012
Re: K113429
Trade/Device Name: SafeTouch PSV winged Infusion Set with/without filter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: March 6, 2012 Received: March 7, 2012
Dear Ms. Oswald:
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.
3
Page 2- Ms. Oswald
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:_
Device Name: SafeTouch PSV winged Infusion Set with/without filter
Indications for Use:
The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously or to sample blood. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
AND/OR
(21 CFR 801 Subpart C)
(Division Sign-Off)
3/12/2012
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K113429
SafeTouch PSV winged Infusion Set with/without filter
-4.1-