(175 days)
Not Found
No
The summary describes a mechanical safety mechanism for a standard infusion set and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is used for administering fluids and drugs, or for blood sampling. While it facilitates the delivery of therapeutic substances, the device itself does not directly provide a therapeutic effect. Its primary function is a delivery mechanism and safety measure against needlestick injuries.
No
The device is described as an administration set for fluid/drug infusion and blood sampling, and includes a safety mechanism. It is not indicated for diagnostic purposes but rather for administering substances or collecting samples.
No
The device description clearly describes a physical medical device (needle and administration set with a safety mechanism) and the performance studies focus on non-clinical tests related to physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary purpose is the administration of fluids, drugs, and blood sampling through surgically implanted vascular ports. It also includes a safety mechanism for needlestick prevention. This describes a device used for direct patient care and access to the circulatory system, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces its use as an "intravascular administration set" to access vascular ports for infusion and blood sampling.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing samples.
Therefore, this device falls under the category of a medical device used for patient treatment and access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. Secondly it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries.
Product codes
FPA
Device Description
The Nipro SafeTouch Huber Infusion Set is a standard non-coring Huber type needle and administration set with an integrated safety mechanism to prevent in accidental needlesticks. This device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgically implanted subcutaneous vascular ports
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
Non-clinical tests performed and included in this submission include:
- . Dimensional
- Mechanical .
- . Performance
- Biocompatibility
The results of the non-clinical tests and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO SafeTouch Huber Infusion Set performs equivalent to the predicate device and is safe and effective when used as intended.
Key Metrics
Not Found
Predicate Device(s)
EXEL SecureTouch Safety Huber Infusion Set
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for Nipro. The logo consists of a stylized, abstract symbol on the left and the word "NIPRO" in bold, sans-serif font on the right. The symbol appears to be two interlocking or overlapping shapes, possibly representing a stylized "N" or an infinity symbol.
IPRO MEDICAL CORPORATION 3150 N.W. 107 Avenue Miami, Florida 33172 Tel.: (305) 599-7174 Fax: (305) 599-8454
OCT 2 1 2008
510(k) Summary NIPRO SafeTouch Huber Infusion Set
807.92(a) (1)
Applicant: Establishment Reg.: Nipro Medical Corporation 1056186
Contact Person:
Jessica Oswald Regulatory Affairs Specialist
April 16, 2008 Date of summary preparation:
807.92(a) (2)
Trade Name: NIPRO SafeTouch Huber Infusion Set Common Name: Huber Infusion Set Classification Name: (21 CFR 880.5440) Product Code: 80 FPA
807.92(a) (3)
Legally marketed substantial equivalent device: EXEL SecureTouch Safety Huber Infusion Set
807.92(a) (4)
Description of device:
The Nipro SafeTouch Huber Infusion Set is a standard non-coring Huber type needle and administration set with an integrated safety mechanism to prevent in accidental needlesticks. This device is designed for use with a vascular access infusion system and is intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports in a standard manner for the purposes of fluid or drug infusion and blood sampling.
807.92(a) (5)
Indications for Use:
This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. Secondly, it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries.
807.92(a) (6)
Comparison of technological characteristics:
1
Image /page/1/Picture/0 description: The image shows the Nipro logo. The logo consists of a stylized, intertwined ribbon-like symbol on the left, followed by the word "NIPRO" in bold, sans-serif font. The color scheme is black and white, with the logo elements appearing in black against a white background.
NIPRO MEDICAL CORPORATION 3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
The NIPRO SafeTouch Huber Infusion Set is substantially equivalent to the predicate device in the following technological characteristics –
- Design .
- Physical characteristics .
- . Basic Scientific Technology
- Intended Use .
807.92(b) (1)
Non-clinical tests performed and included in this submission include:
- . Dimensional
- Mechanical .
- . Performance
- Biocompatibility ◆
807.92(b) (3)
Conclusions drawn from non-clinical and clinical tests: The results of the non-clinical tests and the comparison of technological characteristics with the predicate device demonstrate that the NIPRO SafeTouch Huber Infusion Set performs equivalent to the predicate device and is safe and effective when used as intended.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2008
Ms. Jessical Oswald Regulatory Affairs Specialist Nipro Medial Corporation 3150 North West 107th Avenue Miami, Florida 33172
Re: K081210
Trade/Device Name: NIPRO SafeTouch Huber Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 2, 2008 Received: October 3 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D. 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: NIPRO SafeTouch Huber Infusion Set
Indications for Use:
This product is a safety intravascular administration set and is indicated for the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports. Secondly it incorporates a safety mechanism to help protect against exposure to blood borne pathogens caused by accidental needlestick injuries.
Ln. Arimid
Jivision Sign-Off) livision of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
メ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
NIPRO SafeTouch Huber Infusion Set
-4.1-