(78 days)
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).
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
The provided text is a 510(k) summary for the SpermCatch device, which is an assisted reproduction medium. It states that the device is "as safe and effective as the predicate device" based on "clinical trials and comparative testing." However, the document does not include specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested.
Therefore, I cannot fully complete the table and answer all questions directly from the provided text. The information below reflects what can be extracted and highlights what is missing.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document claims the device is "as safe and effective as the predicate device." | Not explicitly stated in the document. The document claims the device is "as safe and effective as the predicate device." |
Missing Information: The document does not provide quantifiable acceptance criteria (e.g., minimum percentage reduction in sperm motility, range of viability maintained, etc.) or specific numerical results from the device's performance that directly address such criteria.
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "clinical trials and comparative testing" but does not provide details on sample size for any test sets.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe how ground truth was established for any "clinical trials" or "comparative testing" that might have been conducted.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an assisted reproduction medium, not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance in that context.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (a liquid medium), not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the device's function (slowing sperm motility), ground truth would likely involve measurements of sperm motility, viability, and potentially fertilization rates, but the exact method for establishing this is not detailed.
-
The sample size for the training set:
- Not applicable/Not specified. As a medical device (a liquid medium) rather than a machine learning algorithm, the concept of a "training set" in the AI sense does not apply directly. If "training set" refers to data used to formulate the product, this is not disclosed.
-
How the ground truth for the training set was established:
- Not applicable/Not specified. See above.
{0}------------------------------------------------
AUG 1 0 2001
EXHIBIT 2 NidaCon International AB Mölndalsvägen 22 S-412 63, Göteborg, Sweden Tel +46-31-405440 Fax +46 31-405415
Contact: Paul V. Holmes MSc, PhD, DrMedSc., General Manager May 23, 2001 510(k) Summary of Safety and Effectiveness
-
- 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
-
- Indications for Use (intended use) The product is intended to be used for decreasing the motility and movements of sperm before ICSI.
-
- 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
-
- 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.
-
- Conclusion: Based on the similarity of composition, product testing results, and intended use, SpermCatch is substantially equivalent to the predicate device named above.
Page 8
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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 (301) 594-4639. Additionally, for questions on the promotion diagnosic devices), please contact the Office of Compliance at (301) 594-4639. 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 (301) 443-6597 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)
{2}------------------------------------------------
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.
§ 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.