SPERMCATCH

K011607 · Nidacon International AB · MQL · Aug 10, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K011607
• Device Name: SPERMCATCH
• Applicant: Nidacon International AB
• Product Code: MQL · Obstetrics/Gynecology
• Decision Date: Aug 10, 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 decreasing the motility and movements of sperm before ICSI. SpermCatch™ is a medium designed to modulate sperm motility in a physiological manner, to facilitate injecting a single sperm into an oocyte (ICSI). ICSI is an available procedure in Assisted Reproduction Technology (ART).

Device Story

SpermCatch is a sterile, isotonic salt solution used in assisted reproduction clinics. It serves as a direct replacement for PVP (polyvinylpyrrolidone) products. The device is used by embryologists or clinicians to slow down sperm motility prior to the ICSI procedure. By modulating sperm movement in a physiological manner, it facilitates the capture and injection of a single sperm into an oocyte. The device is supplied in 100 uL volumes and is ready-to-use.

Clinical Evidence

The submission states that results of clinical trials and comparative testing against the predicate product indicate the device is as safe and effective as the predicate. No specific numerical data, sample sizes, or statistical metrics were provided in the summary document.

Technological Characteristics

Sterile, filtered, isotonic salt solution. Supplied in 5x100 uL volumes. Ready-to-use liquid medium. No electronic, software, or mechanical components.

Indications for Use

Indicated for use in Assisted Reproduction Technology (ART) to decrease sperm motility and movement to facilitate the injection of a single sperm into an oocyte during Intracytoplasmic Sperm Injection (ICSI).

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

• PVP (K991391)
• PVP (K991343)
• PVP (K001967)

Submission Summary (Full Text)

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## AUG 1 0 2001

K011607

## 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 May 23, 2001 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: SpermCatch 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: PVP, K991391, PVP, K991343, PVP, K001967
- 3. Indications for Use (intended use) The product is intended to be used for decreasing the motility and movements of sperm before ICSI.
- 4. Description of the Device: SpermCatch is optimised for slowing sperm motility prior to ICSI and is ready-to-use in direct replacement for PVP products. SpermCatch is supplied as a sterile (filtered), isotonic salt solution. Volume 5x100 uL. Product No. SC-100
- 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, SpermCatch is substantially equivalent to the predicate device named above.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2001

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

Re: K011607

SpermCatch™ Assisted Reproduction Media (ART) Dated: May 23, 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 makes the device referenced above and we have decembed the We have reviewed your Section 510(K) notications of micher to the exclusive) to legally marketed predicate devices of to the device is substantially equivalent (tot the mackness to base and under de valient of the American on to devices on to devices of to devices of to devices of to devices of to marketed in interstate commerce provisions of the Federal Food, Doug, and Cometic Act (Act, You may).
that have been reclassified in accordance with the provisions of the con that have been reclassified in accordance with in provisions of the porcel controls provisions of the Act .
therefore, market the device, subject to the general controls prov therefore, market the device, subject of the general colitions provincials of the reast of the ling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premater Approval), it nay be subject If your device is classified (see above) into entre class it (spocar conde in the Code of Federal Regulations,
to such additional controls. Existing major regulations affect to such additional controls. Existing major regulations arecultures with his Current Good Manufacturing
Title 21, Parts 800 to 895. A substantially equivalent decembriation Title 21, Parts 800 to 895. A substantaliy equired at a sunical Devices Seneral regultion (21 CFR Parts regultion (21 CFR Part Practice requirements, as set forth in the Quality System REDA) will verify arch such such such such such as annumients 820) and that, through periodic QS inspections, the Pood and Programs of Amay publish further announcements to comply with the GMP regulation may result in response to your prematice notification submission doss not
conceming your device in the Federal Register . Please not of the concerning your device in the Federal Register. Ticase noter and respense to your f
affect any obligation you might have under sections 531 through 542 of the Act for devices arroot any Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarks in order in the FDA finding for your device and This letter will allow you to begally marketed predicated in your of the promises of the 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 additionally 809.10 to rin_vitr If you desire spectic advice for your devee of Our lance at [phone]. Additionally, for questions on the promotion diagnosic devices), please contact the Office of Compliance at [phone]. Also, please met the regulation entitled, "Misbranding by reference to premarket notification" (2). Other general information on your of entitled, "Misbanding by reterence to prematic nomical of Schul Manuscumsismon anist of the number (800)
responsibilities under the Act may be obtained from the Division of S responsibilities under the Rechner tronices tremet address "http://www.fda.gov/cdrh/dsmaddsmamain.html".
638-2041 or [phone] or at its internet address "http://www.fda

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_KO11607

Device Name: SpermCatch™

Indications for Use: SpermCatch™ is a medium designed to modulate_sperm motility in Indications for Use: SpermCutch - is a tincusir desgees as occasions into an oocyte (ICSI).
a physiological manner, to facilitate injecting a single spermany (AT). a physiological mailier, to faciliate injoching a salgh of Technology (ART).
ICSI is an available procedure in Assisted Reproduction Technology (ART).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use***_****_*\$\checkmark\$

Over the Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)

Vlavene Beardon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.