Medi-Tech International Corporations Easy-View Mitts are intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.

Device Description

The Medi-Tech International Corp. Protective Restraint is a protective restraint device which is intended for medical purposes to control the movement of a patient's hand or finger movements thereby enabling examination or protection of the patient or others. Device Design Materials Used/Physical Properties: The Medi-Tech Protective Restraint is designed similar to those marketed by other manufacturers. Primarily comprised of cotton and polyester material and polyester fiber filling.

AI/ML Overview

The Medi-Tech International Corp. Protective Restraint (Easy-View Mitts, Model #MTRM281) is a protective restraint device intended to control the movement of a patient's hand or finger movements to enable examination or protection of the patient or others, particularly when patients are at risk of disrupting life-saving treatments or causing self-injury.

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

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Safety	The flap opens easily to view the back of the hand; the wrist strap does not compromise circulation.	Result: The flap opens easily to view the back of the hand. The wrist strap, when secured properly, did not compromise circulation.
Effectiveness	The inspection flap performs as intended to allow visualization of the hand when closed.	Result: The inspection flap performs as intended to allow the visualization of the hand.
Function	The strength of the strap limits movement to the extent necessary for treatment, examination, and to prevent self-injury or injury to others, equivalent to the predicate device.	Result: The strength of the strap of the MTRM281 mitt was compared to the predicate device strap and provided similar results, indicating it limits movement as intended.
Physical Integrity & Performance (Bench Testing)	Satisfy functional requirements equivalent to the predicate device for: Fiber Content, Tearing Resistance, Shear Strength, Peel Strength, Breaking Strength, Failure in Sewn Seams, Pilling Resistance, Dimensional Stability, Appearance, Labeling Compliance, Defects, Workmanship, Sharp Edges/Points, Functionality, Colorfastness (Accelerated Laundering, Chlorine Bleach, Non-Chlorine Bleach, Perspiration, Burnt Gas Fumes).	Result: All listed bench tests (FIBER CONTENT (ATTCC 20A), TEARING RESISTANCE OF FABRICS (ELMENDORF) (ASTM D 1424), SHEAR STRENGTH OF HOOK & LOOP TOUCH FASTENERS (ASTM D 5169), PEEL STRENGTH OF HOOK & LOOP TOUCH FASTENERS (ASTM D 5170), BREAKING STRENGTH (ASTM D 5034), FAILURE IN SEWN SEAMS OF WOVEN APPAREL FABRICS (ASTM D 1683), PILLING RESISTANCE: RANDOM TUMBLE (ASTM D 3512), DIMENSIONAL STABILITY TO WASHING (AATCC 150), APPEARANCE AFTER WASHING (VISUAL), F.P. & L. ACT (16 CFR500 OR NIST UNIFORM LAWS & REGULATIONS HANDBOOK 130), COUNTRY OF ORIGIN MARKING (19 CFR 134.11), USE LABELING (VISUAL), CARE INSTRUCTIONS (16 CFR 423), DEFECTS (VISUAL CHECK), WORKMANSHIP (VISUAL CHECK), SHARP EDGES/SHARP POINTS (16 CFR 1500.48 SHARP POINT, 16 CFR 1500.49 SHARP EDGES), FUNCTIONALITY (ITS-M0061), COLORFASTNESS TO ACCELERATED LAUNDERING (AATCC 61), COLORFASTNESS TO CHLORINE BLEACH (AATCC/ASTM TS-001), COLORFASTNESS TO NON-CHLORINE BLEACH (AATCC/ASTM TS-001), COLORFASTNESS TO PERSPIRATION (AATCC 15), COLORFASTNESS TO BURNT GAS FUMES (AATCC 23)) were performed. The bench test results demonstrated that the device satisfies all functional requirements and is as safe, as effective, and performs as well as the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size:
- Non-Clinical Data: One individual, Marilyn Geiger, Medi-Tech International Corporation's Product Manager, was used for the "Non-Clinical Data" tests (Safety, Effectiveness, Function).
- Bench Testing: The document does not specify the number of units or samples tested for each of the bench tests (e.g., how many fabric swatches for tearing resistance, how many mitts for seam failure). The tests were performed by Intertek testing facility.
Data Provenance: Retrospective, as these tests were conducted to demonstrate substantial equivalence to an already marketed device (J.T. Posey Company Protective Restraint K963413). The document doesn't specify country of origin for the data beyond the testing facility (Intertek) being utilized.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Non-Clinical Data: One "expert" (Marilyn Geiger, Product Manager) conducted the tests and reported the results. Her specific qualifications beyond being the company's Product Manager are not detailed in the provided text. No independent expert consensus was explicitly stated.
Bench Testing: The testing was performed by Intertek, a third-party testing facility. While not explicitly stated as "experts," Intertek is a recognized testing institution, implying their personnel are qualified to conduct the specified ASTM and AATCC tests. No ground truth was established by human consensus for these physical tests; they are objective measurements against established standards.

4. Adjudication method for the test set

Non-Clinical Data: No explicit adjudication method (like 2+1 or 3+1) is mentioned. The testing appears to have been observed and reported by a single individual (Marilyn Geiger).
Bench Testing: The concept of "adjudication" as typically applied to clinical or image-based studies doesn't apply directly here. The bench tests involve objective measurements and visual inspections against defined criteria and standards. The results would be objectively determined by the testing equipment and qualified technicians at Intertek.

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 MRMC comparative effectiveness study was done. This device is a physical protective restraint and not an AI-assisted diagnostic or therapeutic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

No standalone algorithm performance study was done, as this is a physical medical device, not a software algorithm or AI.

7. The type of ground truth used

Non-Clinical Data (Safety, Effectiveness, Function): The ground truth was based on observational assessment and comparison to the predicate device by the Product Manager. The "ground truth" was essentially the subjective judgment that the device performed "as intended" and "similar" to the predicate.
Bench Testing: The ground truth was based on objective physical measurements against established industry standards (e.g., ASTM, AATCC) and visual inspections for compliance with design specifications (e.g., labeling, workmanship, sharp edges). The predicate device served as a comparative benchmark for several functional and material properties (e.g., strap strength, material composition).

8. The sample size for the training set

No specific training set in the context of machine learning or AI is mentioned, as this is a physical medical device. The "training" for such a device would typically involve design, engineering, and manufacturing processes, not data-driven algorithm training.

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

Not applicable, as there is no training set in the context of AI/ML for this device. The design and development of the device would have been guided by engineering principles, material science, and regulatory requirements, and benchmarked against existing devices.

Summary

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K110377

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APR 2 5 2011

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Medi-Tech International Corp. Protective Restraints

510(k) Summary

SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

SUBMITTER INFORMATION

NAME:	Medi-Tech International Corp.	TELEPHONE:	718-875-4535
ADDRESS:	26 Court Street - Suite 1301Brooklyn, NY 11242	CONTACT:	Marilyn Geiger
		DATE:	April 19, 2011

DEVICE NAMES:

NAME:

Easy-View Mitts, Model #MTRM281

Protective Restraint COMMON NAME:

CLASSIFICATION NAME: Restraint, Protective (FMQ)

PREDICATE OR LEGALLY MARKETED DEVICE:

J.T.POSEY COMPANY Protective Restraint (K963413)

DEVICE DESCRIPTION:

The Medi-Tech Protective Restraint is designed similar to those marketed by other manufacturers.

DEVICE INTENDED FOR USE:

Medi-Tech International Corporations Protective Restraint is intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.

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K10377

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Medi-Tech International 510(k) Safety & Effectiveness Summary

Characteristic	Medi-Tech International Corp. Device	Other Device
Materials	Primarily comprised of cotton and polyester material and polyesterfiber filling	Same
Sizes	Target Population: Adult - Male or FemaleOne Size (Universal) - fits all adultsFits either handNot for Pediatric Use	Same
Length of use	Doctor must prescribe every 24 hours	Same
Level ofPatientActivity	Mildly agitatedTreatment interference by patient	Same

TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE

SUBSTANTIAL EQUIVALENCE CLAIM:

Medi-Tech International Corp. Mitts are similar in indications, design and features to various Protective Restraints that the FDA has found to be substantially equivalent to pre-amendment devices. The following is such a device:

Manufacturer	Product	510(k) Number
J.T.Posey Company	Restraint, Protective	K963413

SUBSTANTIAL EQUIVALENCE COMPARISON:

	Medi-Tech International Corp.	J.T. Posey Company
Indication	Patients accessed at risk ofdisrupting life-saving treatments orself injury.	Patients accessed at risk ofdisrupting life-saving treatments orself injury.
Mode ofOperation	Insert patient's hand. Wrapwrist strap around wrist.	Insert patient's hand. Wrapwrist strap around wrist.
Material	Cotton, Polyester & Polyester Fiber	Cotton, Polyester & Polyester Fiber
Sterility	Non-Sterile/Reusable	Non-Sterile/Reusable

The determination of substantial equivalence is not based upon an assessment of any performance data, clinical or non-clinical.

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K110377

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Medi-Tech International 510(k) Safety & Effectiveness Summary

SUMMARY OF NON-CLINICAL DATA

The MTRM281 mitt was tested on Marilyn Geiger, Medi-Tech International Corporations Product Manager and found to be equivalent to the J.T. Posey predicate device:

Test: Safety The flap opens easily to be able to view the back of the hand. The wrist strap was wrapped around the smallest part of the wrist, through · the plastic ring and secured with the hook and loop fastener.
Result: The strap did not compromise circulation.
Test: Effectiveness The hook and loop fastener was detached and the inspection flap was pulled back to expose the hand. The inspection flap was closed by tucking it into the end of the mitt and the hook and loop closure was pressed firmly together to close it.
Result: The inspection flap performs as intended to allow the visualization of the hand.
Test: Function The strength of the strap was tested and was shown to limit the movement to the extent necessary for treatment, examination and to prevent self-injury or injury to others.
Result: The strength of the strap of the MTRM281 mitt was compared to the predicate device strap and provided similar results.

The non-clinical tests demonstrated that the MTRM281 mitt is as safe, as effective and functions the same and as well as the predicate device with no adverse effects or complications.

SUMMARY OF BENCH TESTING

Comparative bench testing was performed by the Intertek testing facility to evaluate the physical integrity and performance of the device and it's predicate.

Tests performed:

· FIBER CONTENT (ATTCC 20A)
· TEARING RESISTANCE OF FABRICS (ELMENDORF) (ASTM D 1424)

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KII0337

Medi-Tech International 510(k) Safety & Effectiveness Summary

Tests performed: (continued)

· SHEAR STRENGTH OF HOOK & LOOP TOUCH FASTENERS (ASTM D 5169)
· PEEL STRENGTH OF HOOK & LOOP TOUCH FASTENERS (ASTM D 5170)
· BREAKING STRENGTH (ASTM D 5034)
· FAILURE IN SEWN SEAMS OF WOVEN APPAREL FABRICS (ASTM D 1683)
· PILLING RESISTANCE: RANDOM TUMBLE (ASTM D 3512)
· DIMENSIONAL STABILITY TO WASHING (AATCC 150)
· APPEARANCE AFTER WASHING (VISUAL)
· F.P. & L. ACT (16 CFR500 OR NIST UNIFORM LAWS & REGULATIONS
· HANDBOOK 130)
· COUNTRY OF ORIGIN MARKING (19 CFR 134.11)
· USE LABELING (VISUAL)
· CARE INSTRUCTIONS (16 CFR 423)
· DEFECTS (VISUAL CHECK)
· WORKMANSHIP (VISUAL CHECK)
SHARP EDGES/SHARP POINTS (16 CFR 1500.48 SHARP POINT, 16 CFR 1500.49 ·SHARP EDGES)
· FUNCTIONALITY (ITS-M0061)
· COLORFASTNESS TO ACCELERATED LAUNDERING (AATCC 61)
· COLORFASTNESS TO CHLORINE BLEACH (AATCC/ASTM TS-001)
· COLORFASTNESS TO NON-CHLORINE BLEACH (AATCC/ASTM TS-001)
· COLORFASTNESS TO PERSPIRATION (AATCC 15)
· COLORFASTNESS TO BURNT GAS FUMES (AATCC 23)

The bench test results demonstrate that the device satisfies all functional requirements and the device is as safe, as effective and performs as well as the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Mr. Marilyn Geiger Medi- Tech International Corporation 26 Court Street - Suite 1301 Brooklyn, New York 11242

Re: K110377

Trade/Device Name: Protective Restraint Regulation Number: 21 CFR 880,6760 Regulation Name: Protective Restraint Regulatory Class: I Product Code: FMO Dated: February 8, 2011 Received: February 10, 2011

APR 2 5 2011

Dear Mr. Geiger:

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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Page 2- Mr. Geiger

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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

for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K110377

Indications for Use

510(k) Number: K110377

Device Name: Protective Restraint, Easy-View Mitts #MTRM281

Indications For Use: Medi-Tech International Corporations Easy-View Mitts are intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.

Contraindication: Not for Pediatric Use

Prescription Use RX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ald C. Chayna 4/25/11

Division Sign-Off) Vivision of Anesthesiology, General Hospital nfection Control, Dental Devices

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:10(k) Number: K110377

Regulation Number and Section

§ 880.6760 Protective restraint.

(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.