The intended use of this device is for the removal of 90° winged infusion sets, THE GRIPPER™, and VasTack™, having a 1-1/2" needle or shorter from implanted ports and the containment of the used needle until placed in a sharps container.

Device Description

The MedCare Medical Group's HuberLoc is a device designed to assist in the removal and containment of Huber needles. The device consists of three plastic molded components; an inner slide and an outer housing, right and left halves. The HuberLoc is slid over the Huber needle, so the needle cannula is in the slot of the forks. Pressure is applied to the top of the HuberLoc to support the skin and the infusion port with your thumb. The first and middle finger of the same hand pull on the wings of the inner slide, in opposition to the thumb pressure. This action removes the Huber needle and draws it into the outer housing. The inner slide locks into place and contains the needle. The operation utilizes an easy one handed technique. This eliminates any rebound reflex. The HuberLoc is provided sterile, disposable, and for single patient use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HuberLocTM device:

Based on the provided K973497 510(k) summary, there is no explicit mention of acceptance criteria or a formal study with defined endpoints and statistical analysis to prove the device meets acceptance criteria. This submission focuses on demonstrating substantial equivalence to a predicate device, as was common for 510(k) submissions in 1998 for lower-risk devices.

Therefore, many of the requested sections below cannot be fully populated as they are not detailed in this type of regulatory submission.

Acceptance Criteria and Device Performance

There are no formal acceptance criteria or quantitative performance metrics explicitly stated in the 510(k) summary. The summary describes the device's function and claims without providing specific numerical targets for success.

Acceptance Criteria	Reported Device Performance
Not specified	Assists in the removal and containment of Huber needles.
Not specified	Eliminates any rebound reflex.
Not specified	Utilizes an easy one-handed technique.
Not specified	Reduces the potential of an inadvertent needle stick.
Not specified	Contains the removed contaminated sharps.

Study Information (Based on available documentation)

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

Sample Size: Not specified. The document does not describe a formal test set or corresponding sample size.
Data Provenance: Not specified. There is no mention of a study, so no data provenance is available.

2. 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. There is no mention of a ground truth establishment process or experts in this 510(k) submission.

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

Not applicable. No formal test set or adjudication method is described.

4. 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

Not applicable. This document describes a mechanical device, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.

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

Not applicable. This device is a mechanical tool for needle removal and containment, not an algorithm.

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

Not applicable. No formal ground truth was established as part of this submission. The device's functionality is described, and its "performance" is implied through its design features.

7. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/algorithm-based system requiring a training set.

8. How the ground truth for the training set was established

Not applicable. As above, no training set was used.

Summary of Device Claims and Basis for Clearance:

The HuberLocTM device received 510(k) clearance based on demonstrating substantial equivalence to a predicate device (Doyle Extractor, K955748). The key differences highlighted are that the HuberLocTM provides containment of the removed sharps, which the predicate device does not. The claims revolve around reducing needle sticks, enabling one-handed operation, and eliminating rebound reflex.

This type of 510(k) submission focuses on comparing the new device's design, materials, and intended use to an already legally marketed device, rather than requiring extensive clinical trials or performance studies with explicit acceptance criteria. The "proof" is largely based on the engineering design and functional description, compared to an existing device with a similar purpose.

Summary

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K973497
JAN 13 1998

510(k) Summary: (1)

This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.

(1) Submitted By:
MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446

Contact Person:

Craig J. Bell Director of Research and Development (603)352-3230

Name of Device: (2)
HuberLocTM

Classification Name:

Unknown

Identification of Predicate Devices: (3)
510(k) Number K955748 Doyle Extractor Product Code: MSDX-12 Med Stream Medical, Inc. Streetsboro, OH 44241

Description of Device Subject to Premarket Notification: (4)

CONFIDENTIAL INFORMATION MedCare Medical Group, Inc.

Page 10 of 13

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the outer housing. The inner slide locks into place and contains the needle. The operation utilizes an easy one handed technique. This eliminates any rebound reflex. The HuberLoc is provided sterile, disposable, and for single patient use.

(ર) Intended Use of the Device:

The HuberLoc is a single patient, single use, disposable device which is Intended to assist in the procedure of removing Huber needles.

(6) Technological Characteristics

The HuberLoc provides a device that can reduce the potential of an inadvertent needle stick from the removal of a Huber needle. The HuberLoc eliminates the use of a stabilizing hand and the rebound reflex. The HuberLoc relies on a mechanical removal of the Huber needle and a containment means once the Huber needle is removed. The predicate device assists in the removal, but does not contain the removed contaminated sharps.

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Image /page/2/Picture/2 description: The image shows a partial view of the Department of Health & Human Services USA logo. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The central part of the logo features a stylized design, possibly representing a symbol or emblem associated with the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 1998

Mr. Craig J. Bell ·Director of Research and Development MedCare Medical Group, Incorporated 234 Old Homestead Hiqhway, Route 32 East Swanzey, New Hampshire 03466

Re : K973497 HuberLoc™ Needle Removal & Containment Trade Name: Device Regulatory Class: Unclassified Product Code: LJT November 13, 1997 Dated: November 14, 1997 Received:

Dear Mr. Bell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895... A. .... . . substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Bell

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(J) Indications For Use Statement

510(k) Number (if known): K973497

Device Name: HuberLockM

Indications For Use:

(THE GRIPPER Is a trademark of SIMS Delter and VasTack Is a trademark of Gish Blomedical.)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Cespedes

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K973477

Prescription Use L (Per 21 CFR 801.109)

ાર

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

CONFIDENTIAL INFORMATION MedCare Medical Group, Inc.

Page 12 of 13

Regulation Number and Section

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.