The Medcomp® Power Injectable Huber Needle Safety Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through implanted vascular access ports. The Medcomp® Power Injectable Huber Needle Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 19 gauge and 20 gauge non-coring Huber style needles and 2 ml/sec for 22 gauge noncoring Huber style needles.

Device Description

The Power Injectable Safety Huber Needle is composed of a sharpened anti-coring Huber style needle for port septum access having a safety feature which is manually operated and will prevent accidental needle sticks when advanced which is connected to a conventional style extension set for attachment to standard IV/Drug infusion line sets.

The proximal end of the needle cannula is adhesively sealed to the molded housing which contains a glue well and fluid thru hole thru hole leads to the distal end of the extension line set that is also adhesively bonded in the molded housing. The distal end of the extension tubing contains a female luer connector with removable dust cap on the proximal end creating a fluid path from the needle tip thru the female luer. The infusion set is also offered in a configuration where the extension tubing contains a Y-Site connector with removable dust cap placed midway between the needle and the female luer connector. The extension tubing contains purple pigment to indicate its use for high pressure. The Y portion of the connector is a molded female luer that is sealed with a removable dust cap. A non-removable pinch clamp is located between the female luer and needle cannula. On line sets with a Y-Site connector, two pinch clamps are present located between the female luer and the Y-Site and the Y-Site and the needle cannula. The pinch clamps are designed that when engaged, fluid flow is restricted thru the extension tubing.

The needle cannula is constructed with a Huber style anti-coring needle tip. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

The molded wing housing is of plastic construction and contains rigid protruding wings.

The molded wing housing is snap fitted into the molded housing via a securement post. The wing housing is of plastic construction with a protruding wing designed flush with the under surface of the housing. The wing housing contains a thru hole that easily slides over the needle cannula. The wing housing contains a torsion spring that is positioned on a post and is orientated in a positioning channel. The torsion spring is in a compressed state until the molded housing is removed from the wing housing at which time the torsion spring is automatically activated. The wing housing consists of a base to which the securement bag is adhesively bonded.

The molded housing is connected to the wing housing via the securement bag. The securement bag (a polyester film lamination) is adhesively bonded to the molded housing and the wing housing. The securement bag is compressed (accordion style) between the molded housing and wing housing and is of length sufficient to activate the torsion spring and to prevent the needle tip from entering the securement bag area.

In normal operation, the molded housing is activated during removal of the needle from the patient. The wing housing is held firmly in place while the molded housing is disengaged. The molded housing is disengaged from the wing housing by grasping the elevated portion of the molded housing and sliding the molded housing in an upward direction. The molded housing will disengage from the wing housing and will advance until the torsion spring is past the needle tip at which time the torsion spring will snap over the needle access hole. Upon spring activation, there will be an audible click sound as the spring snaps against the wing housing. The securement bag prevents the molded housing from advancing off the needle cannula and the torsion spring prevents the needle from advancing out of the housing.

Prior to use, the exposed portion of the needle cannula, including the sharpened needle tip area, is coated with a silicone fluid to render the needle lubricious and to reduce the insertion (penetration) and drag force to industry acceptable values.

Each needle size has I.D. Rings located within the pinch clamp to identify the appropriate infusion rate for the noted needle gauge size. Components will be assembled by the manufacturer into standard configurations with or without the "Y-Site" and packaged.

AI/ML Overview

The provided text describes a medical device, the Medcomp Power Injectable Safety Huber Needle, and its FDA 510(k) clearance. However, the document does not contain the information requested in your prompt regarding acceptance criteria for a study proving device performance, sample sizes, expert qualifications, or details of efficacy studies (MRMC or standalone).

The document is a regulatory approval letter and a summary of the device for FDA submission. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics.

Here's what can be extracted based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document.	Pressure ratings for each needle gauge size are determined through pressure testing. These ratings are located on the I.D. Ring within the infusion line clamp. (Specific values or pass/fail criteria are not provided).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified.
Data Provenance: Not specified. The data appears to be from "Bench / Performance Data" (laboratory testing), not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable as this document does not describe a study involving expert-established ground truth for a test set. The performance data mentioned relates to engineering tests (pressure testing).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This document does not describe a study involving adjudication of a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states: "Clinical studies were not deemed necessary since no changes have been made to the design, packaging, sterilization or indications for use that would have any effect on the safety and effectiveness of the device when compared to the legally marketed predicate device." This device is a physical medical needle, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical needle, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the "Bench / Performance Data" mentioned, the "ground truth" would be the direct measurements obtained from the physical pressure testing of the needles, adhering to established engineering standards relevant to pressure ratings for such devices. No medical "ground truth" (like pathology or expert consensus) is discussed for this type of device.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not a machine learning or AI device that requires a training set with established ground truth.

In summary, the provided document is a regulatory submission for a physical medical device (needle) and focuses on demonstrating substantial equivalence through bench testing, not on clinical efficacy studies with detailed acceptance criteria, expert reviews, or AI performance metrics as requested in your prompt.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 24, 2017

Medical Components Inc. Timothy Holwick Regulatory Associate 1499 Delp Drive Harleysville, PA 19438

Re: K132880

Trade/Device Name: Medcomp Power Injectable Safety Huber Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, Hypodermic, Single Lumen Regulatory Class: Class II Product Code: PTI Dated: September 20, 2013 Received: September 23, 2013

Dear Mr. Holwick:

This letter corrects our substantially equivalent letter of January 8, 2014. 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.

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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 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" (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 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,

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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

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· DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132880

Device Name

Medcomp® Power Injectable Safety Huber Needle

Indications for Use (Describe)

The Medcomp® Power Injectable Huber Needle Safety Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through implanted vascular access ports. The Medcomp® Power Injectable Huber Needle Safety Infusion Set is also indicated for power injection of contral venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 19 gauge non-ooring Huber style needles and 2 ml/sec for 22 gauge non-coring Huber style needles.

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.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2014.01.06 08:05:47 -05'00,

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

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Submitter Information:

Submitter:	MEDCOMP®1499 Delp DriveHarleysville, PA 19438Tel: (215) 256-4201Fax: (215) 256-9191
Contact:	Timothy HolwickRegulatory Associate
Date Prepared:	September 12, 2013
Trade Name:	Medcomp® Power Injectable Safety Huber Needle
Common Name:	Non-Coring (Huber) Needle
Classification Name:	Hypodermic Single Lumen Needle
Classification Panel:	General Hospital
C.F.R. Sections	§880.5570
Product Code:	PTI
Class:	II
Predicate Devices:	K080544, CT Injectable Safety Huber Needle,concurrence date August 14, 2008.

Device Description:

The needle cannula is constructed with a Huber style anti-coring needle tip. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

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The molded wing housing is of plastic construction and contains rigid protruding wings.

Indications for Use:

Comparison to Predicate Devices:

The power Injectable safety Huber needle is substantially equivalent to the predicate device in terms of intended use, basic design, materials, performance, labeling, manufacturing process and method of sterilization.

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Bench / Performance Data:

Pressure testing has been performed on each needle gauge size to determine pressure ratings. Pressure ratings for the appropriate needle gauge is located on the I.D. Ring located within the infusion line clamp.

Clinical studies were not deemed necessary since no changes have been made to the design, packaging, sterilization or indications for use that would have any effect on the safety and effectiveness of the device when compared to the legally marketed predicate device.

Biocompatibility:

Testing for all materials is found in Section 15. All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993.

Technological Characteristics:

Technological similarities between the proposed devices and predicate devices remain the same.

Summary of Substantial Equivalence:

The proposed devices meet the performance criteria of design verification as specified by ISO standards, guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate devices.

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.