K Number

Device Name

Manufacturer

NUMEDIS, INC.

Date Cleared

2007-12-21

(415 days)

Product Code

LYX

Regulation Number

N/A

Type

Traditional

Panel

Ophthalmic

Reference & Predicate Devices

K924165

Predicate For

N/A

Intended Use

LIFE4°C is indicated for storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C).

Device Description

Life49C is sterile, non-pyrogenic, advanced buffered corneal preservation medium which is supplemented with chondroitin sulfate (membrane stabilizer), recombinant human insulin (cell metabolism enhancer), Dextran (osmotic agent), glutathione (antioxidant, free-radical scavenger, enzyme cofactor), stabilized L-glutamine , ATP precursors, nutrient cell supplements, amino acids, vitamins, trace elements, gentamycin, streptomycin and phenol red (pH indicator).

AI/ML Overview

The provided text is a 510(k) summary for a medical device called Life4°C, a sterile medium for hypothermic corneal storage. The document focuses on establishing substantial equivalence to a predicate device, Optisol GS Corneal Storage Media (K924165), rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information regarding acceptance criteria, performance, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.

Here's a breakdown of what can be extracted and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Explicit Acceptance Criteria: Not explicitly stated in terms of quantifiable thresholds for performance metrics. The submission relies on demonstrating substantial equivalence to a predicate device.	Long-term Stability: Tests were performed, but no specific performance metrics (e.g., maximum allowable degradation, acceptable deviation from baseline) or actual results are reported.
	Safety Testing: Tests were performed, but no specific safety endpoints or results are reported.
	Performance Characteristics: Tests were performed, but no specific performance characteristics or results are reported.
	Sterilization Validation: Tests were performed, but no specific criteria or validation results are reported.
	Comparison with Predicate Device: Tests were performed (implicitly to show equivalence in performance), but no direct comparison data or specific metrics are provided.
Intended Use: Storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C).	Implied Performance: The device performs equivalently to the predicate, which is approved for the same intended use. No specific "success rate" or "retention of viability" metrics are provided for Life4°C itself.

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

The document mentions "Non-clinical tests" including "Long-term Stability," "Safety Testing," "Performance Characteristics," "Sterilization Validation," and "Comparison with Predicate Device."
However, it does not provide any details on the sample sizes used for these tests.
Data Provenance: Not specified. It's implied these are internal company tests conducted by Numedis, Inc., but no country of origin or whether they were retrospective or prospective is mentioned.

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

Not applicable / Not provided. The nature of the tests (stability, sterility, safety, performance characteristics of a storage medium) typically does not involve human experts establishing "ground truth" in the same way an AI diagnostic device would. These tests would involve laboratory measurements against established standards or predicate device performance.
The document explicitly states "(b) Clinical tests - Not required," which further indicates no human expert-based ground truth establishment as would be present in a clinical trial.

4. Adjudication method for the test set

Not applicable / Not provided. Since there's no mention of human expert assessment or ground truth establishment in a diagnostic sense, there is no adjudication method described.

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, an MRMC comparative effectiveness study was not done.
The device is a corneal storage medium, not an AI diagnostic device that assists human readers.

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

Not applicable. The device is a corneal storage medium, not an algorithm or AI system. Its performance is evaluated through non-clinical laboratory tests, not standalone algorithm performance.

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

Not explicitly stated in terms of "ground truth" as a diagnostic reference. For tests like long-term stability and sterilization validation, the "ground truth" would be established acceptance limits based on scientific principles and regulatory standards (e.g., cell viability thresholds, sterility assurance levels).
For the "Comparison with Predicate Device," the predicate's established performance serves as a reference.

8. The sample size for the training set

Not applicable / Not provided. The device is a physical sterile medium, not an AI model requiring a training set.

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

Not applicable / Not provided. As there is no AI model or training set, this information is irrelevant to the described device.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Life4°C corneal storage medium to a predicate device (Optisol GS) through non-clinical laboratory tests. It explicitly states that clinical tests were "Not required." Therefore, the detailed information typically requested for AI/diagnostic device performance studies (like expert involvement, ground truth, sample sizes for training/test sets, and MRMC studies) is not present in this document. The "acceptance criteria" are implicitly met by demonstrating performance comparable to the predicate for parameters like stability, safety, and general performance characteristics, though the specific quantifiable criteria and results are not detailed.

Summary

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Life4℃ 510(k) SUMMARY

(510(K) Summary, Required Under 21 CFR 807.87(h))

10/30/06 DATE PREPARED:

COMPANY (APPLICANT) NAME AND ADDRESS

Numedis, Inc. 2 Enterprise Avenue NE #A2 Isanti, Minnesota 55040 U.S.A. Telephone Number: 763-444-9441 Fax Number: 763-444-9364 Email: ibio(@earthlink.net

DEC 2 1 2007

Contact Name: President: Debra L. Skelnik

Official Correspondent:

Mary Ellen Freddo (Official Correspondent) Telephone Number: 603-661-3716 Fax Number: 413-306-4707 Email: mefreddo@ttlc.net QS/RA Senior Executive Consulting 188 Bumstead Road Monson, MA 01057 U.S.A.

DEVICE INFORMATION

Proprietary Name	LIFE4°C
------------------	---------

Common Names	Sterile medium for hypothermic corneal storage
--------------	------------------------------------------------

Classification Names L YX Media, Corneal Storage

Device Classification Information

Regulatory Class:	Unclassified
Product codes:	LYX

{1}------------------------------------------------

Substantial equivalence

Life4°C is substantially equivalent to Optisol GS Corneal Storage Media, K924165 in indications, design, performance, safety and biocompatibility profiles.

Predicate Device

Trade Name:	Optisol GS Corneal Storage Media
Company:	Chiron Intraoptics
510(k) #:	K924165
Date Approved:	October 6, 1992

Intended Use

Life49C is indicated for storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C).

Device Description and Principles of Operation

Materials Used in the Device and Its Components, Including Packaging

Life4°C is a formulated, sterile, 30 ml corneal storage solution for single use. Life4°C is individually packaged in a 30 ml PETG bottle with a HDPE cap and tamper seal. Each Life49C unit is appropriately labeled with lot number and expiration date. Twelve individual Life4°C units are packaged in a PET clamshell with a tamper seal, that is appropriately labeled with lot number and expiration date. Life4°C Instructions for Use are included in the clamshell. The 12 unit clamshell is placed into an outer labeled paperboard box for shipping.

Performance Data

(a) Non-clinical tests

The following tests have been done on Life4°C:

1. Long-term Stability
1. Safety Testing
1. Performance Characteristics
1. Sterilization Validation
1. Comparison with Predicate Device
1. Package Validation
(b) Clinical tests
- Not required.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2007

Numedis, Inc. c/o Ms. Mary Ellen Freddo QS/RA Senior Executive Consulting 188 Bumstead Rd. Monson, MA 01057

Re: K063304 Trade/Device Name: Life4°C

Regulatory Class: Unclassified Product Code: LYX Dated: December 6, 2007 Received: December 6, 2007

Dear Ms. Freddo:

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.

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 (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.

{3}------------------------------------------------

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 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.

M.B. Egorlums, my

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

LIFE4°C is indicated for storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C).

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

and the state of the state of the success of the

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ﻤﻤﺎ (Part 21 CFR 801 Subpart D)

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

L. King Ph.D.
Division Sign-Off

Division Siar Division of Ophthalmic E Nose and Throat Devis

AND/OR

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A