(146 days)
Not Found
No
The description focuses on the mechanical design and safety features of a winged infusion set, with no mention of AI or ML capabilities.
No
A therapeutic device is one that treats or heals a disease or condition. This device is an infusion set used to administer fluids intravenously, which is a supportive function, not a direct therapeutic one.
No
The device is described as an "infusion set" used to "administer fluids intravenously," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines physical components like a winged needle, PVC tubing, and a luer connector, indicating it is a hardware device, not software-only.
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. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description details a needle, tubing, and connector for fluid delivery, not components for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, or any other biological sample for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device for safe and effective fluid delivery and needlestick prevention, not on diagnostic accuracy or performance.
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 to deliver substances into the body, not to analyze substances from the body.
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. Secondly it is designed with an active share 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. An optional 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
patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician / 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)
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.
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.
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 in black and white.
3150 NW 107th Avenue Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621
510(k) Summary - SafeTouch PSV winged Infusion Set with/without filter
Regulatory Affairs Specialist
807.92(a){1)
| Applicant: | Nipro Medical Corporation |
|---|---|
| 3150 NW 107th Ave. Doral FL 33172 | |
| Establishment Reg.: | 1056186 |
| Contact Person: | Jessica Oswald-McLeod |
Date of summary preparation: June 24, 2013
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: K113429 - SafeTouch PSV Winged Infusion Set with or without filter
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. An optional 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. 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 all aspects except the indications for use. We have removed the indication of blood sampling.
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
1
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
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. Inside the circle is a stylized graphic of a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2013
Nipro Medical Corporation Ms. Jessica Oswald-McLeod Regulatory Affairs Specialist 3150 NW 107th Avenue Miami. FL 33172
Re: K132153
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: November 1, 2013 Received: November 6, 2013
Dear Ms. 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.
3
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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.
Kwame O. Ulmer -S
for
Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132153
Device Name
SafeTouch PSV winged Infusion Set with/without filter
Indications for Use (Describe)
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. Secondly it is designed with an active share that requires physical action by the clinician to prevent accidental needlesticks.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
Image /page/4/Figure/11 description: The image shows a document with the header "FOR FDA USE ONLY". It indicates the concurrence of the Center for Devices and Radiological Health (CDRH). The document includes a digital signature by Richard C. Chapman, dated December 4, 2013, at 17:28:59 with a time zone offset of -05'00'.
FORM FDA 3881 (9/13)
PSC Publishing Sers sees ( 101) 44 3-6740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.