PURESPERM

K980814 · Nidacon International AB · MQL · Jun 23, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K980814
• Device Name: PURESPERM
• Applicant: Nidacon International AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jun 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

The product is intended to be used for the separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (IUI).

Device Story

PureSperm is a sperm separation medium used in clinical laboratory settings to prepare human sperm for intrauterine insemination (IUI). The device consists of a buffered salt solution containing a colloidal suspension of silica particles with covalently bound hydrophilic silane. During operation, the medium is used in a density gradient centrifugation process to isolate motile, high-quality sperm from seminal fluid. This purification process helps clinicians select viable sperm for insemination, potentially improving the success rates of fertility treatments. The device is supplied in Type I borosilicate glass bottles.

Clinical Evidence

Clinical trials and comparative testing against predicate products were conducted. Results indicate the device is as safe and effective as the predicate devices.

Technological Characteristics

Buffered salt solution containing colloidal silica particles with covalently bound hydrophilic silane. Formulated for specific pH and osmolality compatible with human sperm. Packaged in Type I borosilicate glass bottles (100, 250, 1000 mL).

Indications for Use

Indicated for the separation and purification of human sperm via density gradient centrifugation for patients undergoing intrauterine insemination (IUI).

Regulatory Classification

Identification

Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).

Special Controls

*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Predicate Devices

• ISolate (K971809)
• Modified Ham's F-10 (K894432)
• Sperm Select (K872849)

Submission Summary (Full Text)

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P191

EXHIBIT 2 NidaCon International AB Mölndalsvägen 26 S-412 63. Göteborg, Sweden Tel [phone] Fax [phone]

## Contact: Paul V. Holmes MSc, PhD, DrMedSc., General Manager February 27, 1998 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: PureSperm® Classification Name/Product Code: 85 MQL(Cervical Cap per 21 CFR 884.5250) Common/Usual Name: Sperm Separation Medium
- Equivalent legally marketed devices: ISolate: K971809, Modified Ham's F-10: 2. K894432, Sperm Select: K872849.
- Indications for Use (intended use) The product is intended to be used for the 3. separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (IUI).
- 4. Description of the Device: The product PureSperm® is a based on a buffered salt solution which contains a colloidal suspension of silica particles, with hydrophilic silane covalently bound to the particles. The pH, osmolality and salts of PureSperm® are formulated to be compatible with human sperm during their centrifugal separation and purification. The product is packaged in three bottle sizes, 100, 250 and 1000 mL, and these bottles, being Type I borosilicate glass, are packaged individually in white virgin-fibre cartons. Both the bottles and the cartons have pharmaceutically approved labels showing batch number, production date and expiration date. In addition, every carton contains an insert with a full description of the product, including instructions for use and precautions.
- 5. Safety and Effectiveness, comparison to predicate devices. The results of clinical trials and comparative testing against predicate products indicates that the new device is as safe and effective as the predicate devices.
- Conclusion: Based on the similarity of composition, product testing results, and 6. intended use, PureSperm® is substantially equivalent to the predicate devices named above.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 23 1998

Nidacon Laboratories c/o Daniel Kamm Regulatory Engineer Kamm and Associates P.O. Box 7007 Dearfield, IL 60015

Re: K980814

PureSperm® (Sperm Separation Medium) Dated: May 18, 1998 Received: June 2, 1998 Unclassified/Procode: 85 MQL

Dear Mr. Kamm:

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, Drug, and Cosmetic Act (Act). 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 practive, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 not affect any obligation you might have under sections 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 80), and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use

510(k) Number K980814

Device Name: PureSperm® Sperm separation medium, Density gradient centrifygution medium

Indications for Use: The product is intended to be used for the separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (IUI).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roler R Sathing
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K980814

Prescription Use OR

Over the Counter Use (Per 21 CFR 801.109)