MASTEL LASER CLEAN ROOM, MODEL EBS-100

K043494 · Mastel Precision Surgical Instruments, Inc. · FYD · Oct 4, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043494
• Device Name: MASTEL LASER CLEAN ROOM, MODEL EBS-100
• Applicant: Mastel Precision Surgical Instruments, Inc.
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Oct 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

Intended Use

Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching. Gradient System is used for separation and purification of human sperm for assisted reproduction procedures. SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

Device Story

FertiPro Reproductive Media Bundle consists of three distinct products for assisted reproduction. Oil for Tissue Culture: colorless liquid paraffin used to cover tissue culture during IVF, embryo culture, and micromanipulation (ICSI/assisted hatching). Gradient System: silane-coated silica particles in HEPES-buffered Earle's Balanced Salts Solution (EBSS) (45%, 90%, 100% concentrations) used for sperm separation and purification. SpermFreeze: HEPES-buffered cryopreservation medium containing 0.4% human serum albumin for human sperm. Devices are used in clinical laboratory settings by embryologists or laboratory technicians. These media facilitate the handling, processing, and storage of gametes and embryos, supporting successful fertilization and preservation outcomes in fertility clinics.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Oil for Tissue Culture: liquid paraffin. Gradient System: silane-coated silica particles in HEPES-buffered EBSS. SpermFreeze: HEPES-buffered medium with 0.4% human serum albumin. All devices are reproductive media and supplements (Product Code: MQL, Class II).

Indications for Use

Indicated for use in assisted reproductive technology (ART) procedures. Oil for Tissue Culture: covers tissue culture for IVF, embryo culture, ICSI, and assisted hatching. Gradient System: separation and purification of human sperm. SpermFreeze: cryopreservation of human sperm.

Regulatory Classification

Identification

Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• OIL FOR TISSUE CULTURE (K011462)
• ENHANCE-S PLUS H (K030116)
• ENHANCE SPERM FREEZE (K030117)

Submission Summary (Full Text)

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Premarket Notification - FertiPro Reproductive Media Bundle

Image /page/0/Picture/1 description: This image contains the text "5. 510(k) Summary" and the date "MAR 23 2006". The image also contains the number "K043494" and the text "FertiPro N.V.". The text "page 1 of 2" is also present in the image.

Industriepark Noord 32 - 8730 Beernem - Belgium - Tel [phone] - Fax [phone]

Submitter's name: Address:

Phone: Fax number:

Name of contact person:

FertiPro N.V. Industriepark Noord 32 Beernem West-Vlaanderen, Belgium 8730 [phone] [phone]

Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] Fax: [phone] Email: [e-mail]

Date the summary was prepared: December 13, 2005

Oil for Tissue Culture Name of the device: Trade or proprietary name: Mineral Oil Common or usual name: Classification name: Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Name of the device: Trade or proprietary name: Common or usual name: Classification name:

Oil for Tissue Culture Reproductive media

Gradient System Sil-Select Plus Gradient System Reproductive media

SpermFreeze SpermFreeze SpermFreeze Reproductive media

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K055494
Fage 2 of 3

The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:

| Device | Ref# | Decided |
|------------------------|---------|------------|
| OIL FOR TISSUE CULTURE | K011462 | 06/13/2001 |
| ENHANCE-S PLUS H | K030116 | 02/12/2003 |
| ENHANCE SPERM FREEZE | K030117 | 03/20/2003 |

Description of the devices:

Oil For Tissue Culture is a colorless liquid paraffin.

Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%.

SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.

Indications:

Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.

Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.

SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

Summary of the technological characteristics of our device compared to the predicate device:

The predicates and these devices were compared in the following areas and found to have exact technological characteristics and to be equivalent.

Formula Special controls Packaging Performance Testing

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized wing or feather shapes.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2006

FertiPro N.V. % Ms. Grace Holland Regulatory Specialist Regulatory Specialist, Inc. 3722 Ave. Sausalito IRVINE CA 92606

Re: K053494 Trade/Device Name: Oil for Tissue Culture, Gradient System, and SpermFreeze Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: February 22, 2006 Received: February 24, 2006

Dear Ms. Holland:

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 rear 20, 1910, and coance 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 (Premarket Approval), 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 docs 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) I ms letter with and in your 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 rryou don't specific at not of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 vours.

Nancy C. Bugdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. Indications for Use Statement Indications for Use

510(k) Number (if known): K053494

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Oil For Tissue Culture is used in covering tissue culture in in-vitro Oll for 1155ae Gallare and micromanipulative procedures such as ICSI and assisted hatching.

> X AND/OR Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Broadon

Andominal, and Ranierous

510(k) Number K053494

Page 1_of _3

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## Indications for Use

510(k) Number (if known): K053494

Device Name: Gradient System

Indications for Use:

Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.

> × AND/OR Over-The-Counter Use __ Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (rucksc oo Nor Withe bacon This 2018 - 17:15 2018 - 17:28 - 17 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tancere Brandon

Page 2 of 3

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053494

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## Indications for Use

510(k) Number (if known): K053494

Device Name: SpermFreeze

Indications for Use:

SpermFreeze is intended to be used as a cryopreservation medium for human sperm.

| Prescription Use | X |
|-----------------------------|---|
| (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 OF NEEDED) (PLEASE DO NOT WRITE BECOW THIS CINE CONTING CONTINE
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Page 3_of _3

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053494