LIFE4C

K063304 · Numedis, Inc. · LYX · Dec 21, 2007 · OP

Device Facts

• Record ID: K063304
• Device Name: LIFE4C
• Applicant: Numedis, Inc.
• Product Code: LYX · OP
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

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

Device Story

Life4°C is a sterile, non-pyrogenic, buffered corneal preservation medium used for the hypothermic storage of human corneas intended for keratoplasty. The solution contains a mixture of chondroitin sulfate, recombinant human insulin, Dextran, glutathione, L-glutamine, ATP precursors, nutrients, amino acids, vitamins, trace elements, gentamycin, streptomycin, and phenol red. It is supplied as a 30 ml single-use solution in a PETG bottle. The device is used in clinical or eye bank settings to maintain corneal viability for up to 14 days at 2-8°C. By providing a stabilized, nutrient-rich environment, the medium supports corneal tissue integrity prior to transplantation, potentially improving surgical outcomes for patients requiring keratoplasty.

Clinical Evidence

No clinical data. Bench testing only, including long-term stability, safety testing, performance characteristics, sterilization validation, and package validation.

Technological Characteristics

Sterile, non-pyrogenic, buffered aqueous solution. Components: chondroitin sulfate, recombinant human insulin, Dextran, glutathione, L-glutamine, ATP precursors, nutrients, amino acids, vitamins, trace elements, gentamycin, streptomycin, phenol red. Packaging: 30 ml PETG bottle with HDPE cap. Single-use. Storage temperature: 2-8°C.

Indications for Use

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

Predicate Devices

• Optisol GS Corneal Storage Media (K924165)

Submission Summary (Full Text)

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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: [e-mail] 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 |

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### 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

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).

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
- 2. Safety Testing
- 3. Performance Characteristics
- 4. Sterilization Validation
- 5. Comparison with Predicate Device
- 6. 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.

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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 [phone]. 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 [phone] or [phone] 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 ________________________________________________________________________________________________________________________________________________________________