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.

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.

AI/ML Overview

The NIPRO SafeTouch Huber Infusion Set is a safety intravascular administration set designed for fluid and drug administration or blood sampling through surgically implanted vascular ports. It also incorporates a safety mechanism to protect against accidental needlestick injuries and associated bloodborne pathogen exposure.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Safety	Incorporates a safety mechanism to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
Effectiveness (Intended Use)	Intended for use as an intravascular administration set to access surgically implanted subcutaneous vascular ports for fluid/drug infusion and blood sampling.
Substantial Equivalence	Demonstrated to be substantially equivalent to the predicate device (EXEL SecureTouch Safety Huber Infusion Set) in: Design, Physical characteristics, Basic Scientific Technology, and Intended Use.
Biocompatibility	Biocompatibility testing performed. (Specific results not detailed, but implied to be acceptable for equivalence).
Non-clinical Performance	Dimensional, Mechanical, and Performance testing performed. (Specific results not detailed, but implied to be acceptable for equivalence).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set" sample size in the context of a clinical study with human subjects. The evaluation primarily relies on non-clinical testing and comparison to a predicate device.
Data Provenance: The document does not mention any human clinical data or its provenance (e.g., country of origin, retrospective/prospective). The study is described as non-clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This question is not applicable as the provided documentation describes a non-clinical study for substantial equivalence rather than a clinical study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

This question is not applicable as the provided documentation describes a non-clinical study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not conducted. The submission focuses on substantial equivalence based on non-clinical testing and comparison to a predicate device, not on comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical medical device (Huber Infusion Set) and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established through:
- Predicate Device Equivalence: The performance and characteristics of the legally marketed EXEL SecureTouch Safety Huber Infusion Set serve as the benchmark for "ground truth" regarding safety and effectiveness for this device type.
- Engineering Specifications and Standards: The "ground truth" for dimensional, mechanical, performance, and biocompatibility testing would be adherence to established engineering specifications and relevant industry standards for medical devices of this class.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical device and not an AI/machine learning system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as above (not an AI/machine learning system).

Summary of the Study and Device Performance:

The NIPRO SafeTouch Huber Infusion Set underwent a premarket notification (510(k)) process, which primarily focused on demonstrating substantial equivalence to a previously legally marketed predicate device, the EXEL SecureTouch Safety Huber Infusion Set.

The study presented in the 510(k) summary consisted of:

Non-clinical tests: Dimensional, Mechanical, Performance, and Biocompatibility testing were performed. The specifics of these tests (e.g., sample sizes for each test, exact methodologies, quantitative results) are not detailed in the summary but are stated to have been included in the full submission.
Comparison of technological characteristics: The NIPRO SafeTouch Huber Infusion Set was compared to the predicate device in terms of design, physical characteristics, basic scientific technology, and intended use.

The conclusion drawn from these tests and comparisons was that the NIPRO SafeTouch Huber Infusion Set performs equivalently to the predicate device and is safe and effective when used as intended. The FDA's issuance of the 510(k) clearance confirms this finding of substantial equivalence. The "acceptance criteria" were met by demonstrating that the device's characteristics and performance are comparable to a known safe and effective predicate device, as evidenced by the non-clinical testing.

Summary

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K081210

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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:

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:

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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.

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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.

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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

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Indications for Use

510(k) Number:

Device Name: NIPRO SafeTouch Huber Infusion Set

Indications for Use:

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-

Regulation Number and Section

§ 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.