(55 days)
The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
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 does not contain any information about acceptance criteria, detailed study designs, or performance metrics in the way a modern AI/software device submission would. This document is a 510(k) summary for a sperm separation medium (PureSperm®), a laboratory reagent, from 1998.
Here's why the requested information cannot be extracted and what can be inferred:
- Device Type: This is a chemical reagent, not a digital health/AI device. Therefore, the concepts of "algorithm performance," "ground truth," "training set," "test set," "multi-reader multi-case (MRMC) studies," or "human-in-the-loop performance" are not applicable in the context of this submission.
- Regulatory Era: This submission dates back to 1998, long before the current rigorous standards for clinical validation of AI/software as a medical device (SaMD) were established.
- Submission Content: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on identical composition, product testing results, and intended use. It does not elaborate on detailed clinical trials or performance studies as would be expected for a diagnostic or therapeutic device today.
Therefore, I cannot fulfill your request for the specific numbered points (1-9) as they relate to AI/software device validation. The information is simply not present in the provided text.
What can be extracted and inferred from the text regarding its safety and effectiveness:
- Claim of Safety and Effectiveness: "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." (Section 5)
- Basis for Equivalence: "Based on the identical composition, product testing results, and intended use, PureSperm® is substantially equivalent to the predicate device named above." (Section 6)
- Predicate Device: PureSperm® (K980814)
In summary, the document states that the device was deemed "safe and effective" and "substantially equivalent" to a predicate based on "clinical trials and comparative testing," but it does not provide any specifics about these trials, their methodology, acceptance criteria, or quantitative results.
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EXHIBIT 3 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 November 18, 1998 510(k) Summary of Safety and Effectiveness
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- Identification of the Device: Proprietary-Trade Name: PureSperm® Classification Name/Product Code: Procode: 85 MQL CFR#: 884.6180 Common/Usual Name: Sperm Separation Medium
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- Equivalent legally marketed devices: PureSperm® K980814
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- Indications for Use (intended use) The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
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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.
- ર. 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.
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- Conclusion: Based on the identical composition, product testing results, and intended use, PureSperm® is substantially equivalent to the predicate device named above.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Daniel Kamm, P.E. Regulatory Engineer Kamm and Associates P.O. Box 7007 Deerfield, IL 60015
Re: K984172 PureSperm® Dated: November 6, 1998 Received: November 20, 1998 Regulatory Class: II 21CFR 884.6180/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 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 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 531 through 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 requlation (21 CFR Part 801 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Robert Daniel C. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting 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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Indications for Use
510(k) Number
984172
Device Name: PureSperm® Sperm separation medium, Density gradient centrifugation medium
Indications for Use: The product is intended to be used for the separation and purification of spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies (ART).
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over the Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Division S | |||
| Division of Reproductive, Abdominal, ENT, | |||
| and Radiological Devices | |||
| 510(k) Number | K984172 |
§ 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.