PURESPERM BUFFER

K011606 · Nidacon International AB · MQL · Jul 12, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K011606
• Device Name: PURESPERM BUFFER
• Applicant: Nidacon International AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Jul 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6180
• Device Class: Class 2

Intended Use

The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.

Device Story

PureSperm® Buffer is a sterile, isotonic salt solution used in assisted reproduction laboratories. It functions as a diluent for PureSperm® or PureSperm® 100 media to create density gradient layers (typically 40% and 80%). These gradients are used during centrifugation to isolate high-quality human sperm from contaminants such as lymphocytes, epithelial cells, immature/abnormal sperm, debris, and bacteria. The device is intended for professional use in clinical settings. It benefits patients by facilitating the preparation of purified sperm samples for reproductive procedures.

Clinical Evidence

No clinical data provided. Safety and effectiveness established through comparative bench testing against the predicate device.

Technological Characteristics

Sterile (autoclaved SAL 10-3) isotonic salt solution. Supplied in 100 ml and 250 ml bottles. No electronic, software, or mechanical components.

Indications for Use

Indicated for use in assisted reproduction procedures to dilute sperm separation media for the preparation of density gradients used to isolate human sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris, and bacteria.

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

• SpermRinse TM (K000621)

Reference Devices

• PureSperm® (K980814)
• PureSperm® (K984172)

Submission Summary (Full Text)

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K011606
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## EXHIBIT 2

NidaCon International AB

Mölndalsvägen 22 S-412 63, Göteborg, Sweden

> Tel [phone] Fax [phone]

## Contact: Paul V. Holmes MSc, PhD, DrMedSc., General Manager June 7, 2001

## 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: PureSperm® Buffer I Classification Name/Product Code: Reproductive Media and Supplements (21 CFR 884.6180) Procode: 85 MQL Common/Usual Name: Assisted Reproduction Media
- 2. Equivalent legally marketed devices: K000621, SpermRinse TM
- 3. Indications for Use (intended use) The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.
- 4. Description of the Device: Buffer PureSperm® Buffer is supplied as a sterile (autoclaved SAL 10-3) isotonic salt solution. It is optimised for the dilution of PureSperm® or PureSperm® 100 in the preparation of density centrifugation gradients for separating and purifying human sperm. Two layers are commonly used for the gradient: 40% and 80%. This system effectively isolates the best sperm from lymphocytes, epithelial cells, abnormal or immature sperm, cell debris and bacteria.. PureSperm® Buffer is CE marked in countries of the European Union. It is supplied in 100 and 250 ml bottles.

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K011606
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- 5. Safety and Effectiveness, comparison to predicate devices. The results of clinical trials and comparative testing against predicate product indicates that the new device is as safe and effective as the predicate device. The intended use of the product is the same.
- 6. Conclusion: Based on the similarity of composition, product testing results, and intended use, PureSperm® Buffer is substantially equivalent to the predicate device named above.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7/10/2001

## JUL 1 2 2001

NidaCon International AB c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015

Re: K011606 PureSperm® Buffer Dated: May 22, 2001 Received: May 24, 2001 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL

Dear Mr. Kamm:

We have reviewed your Section 510(k) notification of intent to market the device received and we have are decembers We have reviewed your Section 510(K) noticallon of the enclosure) to legally marketed precicate devices as to sevices device is substantially equivalent (or the nations to the Medical Device Americal Device American of total Art (4 ct (4 c) marketed in interstate continete provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been recalastined in accordance with and provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the general on provinces, 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 (Premater Approval), it may be subjict If your device is classified (See above) nito chack of copied obtaring or abe found in the Code of Federal Regulations, to such additional controls. Existing major regulation assumes compliance with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialiy equivalia detect C Title ZI, Parts 800 to 893. A subsantary equration (QS) for Medical Device) Central regulation (21 CFR Partic Practice requirements, as set four in the Quality Dystems of Copinistration (FDA) will verify such assumptions. Fallure 820) and that, through periodic QS inspection. In 27 och and 27th, 1 chimston, N. May woldlish further announcements to comply with the GMT regulation in regulatory this response to your premarket notified of the most be dest concerning your device in the Federal Register. Tease noter and respected 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) premarker notification for use and I his letter will allow you to begally marketed predicated in your evelized and one 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 Pat 801 additionally 809.10 for invited If you desire specific advice tor your device of Compliance at [phone]. Additionally, for quest of the promotion diagnosite devices), prease contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information of your entitled, "Misbranding by telefited from the Division of Small Many from the March (800)-free number (800)
responsibilities under the Act may be obtained from the Division of Tesponsibilities under the riter be obtaint address "http://www.fda.gov/cdrl/dsma/dsmamain.html".

Sincerely yours,

Nancy C Brogdon

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

Enclosure (s)

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j) Indications for Use

510(k) Number k01166

Device Name: PureSperm® Buffer

Indications for Use: The product is intended to be used for diluting PureSperm® (K980814 and K984172) sperm separation medium to prepare the different layers of a density gradient. PureSperm® Buffer has been formulated to optimize the function of the original PureSperm®.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Prescription Use /\ OR Over the Counter Use

(Per 21 CFR 801.109) ***_***

Nancy Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K011606

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