(160 days)
SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
SpermSlow™ is a defined medium used by professionals within assisted reproduction designed to slow down the movement and to select the most mature, viable sperm as required for Intracytoplasmatic sperm injection (ICSI). SpermSlow wis principally composed of hyaluronate (HA), the main component of the extracellular matrix, which appears in large amounts between the cumulus cells of the matured oocyte-cumulus complex.
SpermSlow™ is based on a sodium bicarbonate buffered solution containing hyaluronate, HSA (US licensed source), pyruvate, glucose, amino acids, nucleotides, vitamins and antibiotics.
SpermSlow™ is supplied in polypropylene plastic vials with screw top closures in a volume of 0.5ML. Each unit is labelled and the product is presented in four pack containers which also include a package insert.
The provided 510(k) summary for K061145 (SpermSlow™) is very limited in its details regarding performance data and acceptance criteria, typical for a device of this classification and submission year. It primarily focuses on demonstrating substantial equivalence to a predicate device. Therefore, much of the requested information cannot be directly extracted from the provided text.
Here is a summary of what can be extracted and what is not available based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It makes a general claim:
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|
| Presumed: Effective for intended use (sperm slowing and selection for ICSI) | "SpermSlow™ has been tested in a human study. The results show that the product is effective for its intended use." |
| Presumed: Safety profile comparable to predicate / no serious adverse events | "It has been marketed in Europe since May 2004 and there has been no evidence of any serious adverse events in connection with the intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document only states "a human study."
- Data Provenance: The document mentions that the product "has been marketed in Europe since May 2004" and that safety data (absence of serious adverse events) is derived from this European marketing experience. It is not explicitly stated where the "human study" was conducted, but given the European marketing history, it is plausible it was also European data. It is not specified if the human study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The document describes a "human study" but does not detail how effectiveness (sperm slowing, selection, or ICSI outcomes) was assessed or by whom. The "ground truth" for a device that assists in sperm selection would logically be the successful use in ICSI, potentially assessed by embryologists or reproductive specialists, but the document does not elaborate.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable/not provided. The device is a medium used to assist in a biological process (sperm selection), not an AI algorithm or an imaging device that would typically undergo an MRMC study. Therefore, there is no mention of improvement with AI vs. without AI assistance or an effect size.
6. Standalone (Algorithm Only) Performance:
This information is not applicable/not provided. This is a biological medium, not an algorithm.
7. Type of Ground Truth Used:
The document vaguely implies that the "results" of the human study demonstrated the product's effectiveness for its intended use, which is "to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI)." The specific "ground truth" (e.g., successful fertilization rates, embryo development, live birth rates subsequent to ICSI using SpermSlow™-selected sperm) is not specified.
8. Sample Size for the Training Set:
This information is not applicable/not provided. As this is a biological medium and not an AI/machine learning device, there would not be a "training set" in the computational sense. If "training set" refers to developmental or preliminary studies, the size is not mentioned.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/not provided for the same reasons as point 8.
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Kx61145
510(k) Summary
OCT - 2 2006
| Submitted by: | MediCult a/s |
|---|---|
| Møllehaven 12 | |
| 4040 Jyllinge | |
| Denmark | |
| Telephone: + 45 46 79 02 00 | |
| Fax: + 45 46 79 03 00 | |
| Contact person: | Ronald G. Leonardi, Ph.D. |
| R&R Registrations | |
| 991 Cam. Chirimolla | |
| San Diego CA 92131 |
Date Submitted: September 6, 2006
Device Identification:
Trade name: SpermSlow™ Common name: SpermSlowTM Classification name: Reproductive media and supplements (21 CFR 884.6180, Product Code MQL)
Predicated device:
MediCult PVP Medium (K991329).
Description
SpermSlow™ is a defined medium used by professionals within assisted reproduction designed to slow down the movement and to select the most mature, viable sperm as required for Intracytoplasmatic sperm injection (ICSI). SpermSlow wis principally composed of hyaluronate (HA), the main component of the extracellular matrix, which appears in large amounts between the cumulus cells of the matured oocyte-cumulus complex.
SpermSlow™ is based on a sodium bicarbonate buffered solution containing hyaluronate, HSA (US licensed source), pyruvate, glucose, amino acids, nucleotides, vitamins and antibiotics.
SpermSlow™ is supplied in polypropylene plastic vials with screw top closures in a volume of 0.5ML. Each unit is labelled and the product is presented in four pack containers which also include a package insert.
Intended use
SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
Technological Characteristics
The technological characteristics of SpermSlow™ are essentially similar to those of the predicate device; it has the same intended use and is based on a physiological salt solution. However, SpermSlow™ differs in the composition in also containing vitamins, amino acids, nucleotides and hyaluronate instead of polyvinylpyrrolidone.
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Performance data
SpermSlow™ has been tested in a human study. The results show that the product is effective for its intended use.
It has been marketed in Europe since May 2004 and there has been no evidence of any serious adverse events in connection with the intended use.
Product Testing Controls
Frouter Testing Controls
Each batch of SpermSlow™ is tested according to Ph.Eur and USP for sterility and endotoxin and each batch is also tested for viscosity and sperm survival. The results are reported on a certificate of analysis. Stability studies have been performed.
Conclusion
Thus based on the performance testing presented and our experience with the SpermSlow product, we feel that the safety and the effectiveness of the product for its intended use are shown in the present submission and that the product is substantial equivalent to the predicated device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OCT - 2 2006
MediCult a/s c/o Ronald G. Leonardi, Ph.D. President R&R Registrations 9915 Cam. Chirimolla SAN DIEGO CA 92131
Re: K061145
Trade/Device Name: SpermSlow™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: September 27, 2006 Received: September 28, 2006
Dear Dr. Leonardi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 100 years from 1906 to 2006. The logo features the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted circle.
Promoting Public Health
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Page 2 -
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ Issualic of a substance or only other requirements of the Act
that FDA has made a determination that your device and one anaios. You must that FDA has made a delerimiation that your are records agencies. You must or any Federal statules and regulations administered of registration and listing (21)
comply with all the Act's requirements, including, but not many as set comply with all the Act Stequirements, moreans, conviacturing practice requirements as sets CFR Part 807); labeling (21 CFR Part 801); good manara 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 100); 11 CFR 1000 (050 forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The PDA midning of satoration of 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), please If you desire specific advice for your de rice on our has may be any of the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" Also, please note the regulation chittled, "Phisotanation on your responsibilities under (21CFR Part 607.97). Tournal other generational and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
SpermSlow™
Indications For Use:
SpermSlow™ is used to slow down the movement of sperm to allow for the selection of the most mature, viable sperm for Intracytoplasmic sperm injection (ICSI).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
David A. Luyben
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
§ 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.