(112 days)
The product is intended to be used for the separation and purification of human sperm by density gradient centrifugation for intrauterine insemination (IUI).
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.
The provided text is a 510(k) summary for the PureSperm® Sperm Separation Medium. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study outline with performance metrics, sample sizes, ground truth establishment, or any details about AI integration.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
Specifically, the document states:
- "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."
- "Based on the similarity of composition, product testing results, and intended use, PureSperm® is substantially equivalent to the predicate devices named above."
These statements are high-level conclusions and do not provide the detailed scientific study parameters that you have requested in your prompt. There is no table of acceptance criteria, no reported device performance metrics (e.g., sensitivity, specificity, accuracy, or any performance on sperm separation quality), no sample sizes for test or training sets, no information on experts, no adjudication methods, no mention of MRMC studies or AI involvement, and no specifics on how ground truth was established beyond a general mention of "product testing results."
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P191
EXHIBIT 2 NidaCon International AB Mölndalsvägen 26 S-412 63. Göteborg, Sweden Tel +46-31-405440 Fax +46 31-405415
Contact: Paul V. Holmes MSc, PhD, DrMedSc., General Manager February 27, 1998 510(k) Summary of Safety and Effectiveness
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- 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).
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- 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.
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- 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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Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the left side. To the right of the text is a stylized symbol consisting of three curved lines, which is the department's official emblem.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)
§ 884.6180 Reproductive media and supplements.
(a)
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.).(b)
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.