(78 days)
Not Found
No
The device description and intended use focus on a chemical medium for modulating sperm motility, with no mention of AI/ML, image processing, or data-driven algorithms.
No
The device is intended to decrease sperm motility to facilitate a medical procedure (ICSI), not to treat a disease or medical condition.
No
The device is described as a medium intended to decrease the motility and movements of sperm before ICSI, which is a therapeutic rather than diagnostic function. It modulates sperm motility to facilitate a procedure, not to identify or characterize a condition.
No
The device description explicitly states it is a sterile, isotonic salt solution supplied in specific volumes, indicating it is a physical substance (a medium) and not software.
Based on the provided information, yes, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The product is intended to be used for "decreasing the motility and movements of sperm before ICSI." ICSI (Intracytoplasmic Sperm Injection) is a procedure performed in vitro (outside the body) as part of Assisted Reproduction Technology (ART). The product is used to prepare a biological sample (sperm) for this in vitro procedure.
- Device Description: It's a "medium designed to modulate sperm motility." This medium is applied to the sperm sample in vitro.
- Context of Use: It's used in the context of ICSI, which is an in vitro laboratory procedure.
While the description doesn't explicitly state "in vitro diagnostic," the function and context of use strongly align with the definition of an IVD. IVDs are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. In this case, it's used in the context of addressing infertility, which is a "condition."
The fact that it's used to prepare a biological sample (sperm) for an in vitro procedure (ICSI) is a key indicator of it being an IVD.
N/A
Intended Use / Indications for 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).
Product codes
85 MQL
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
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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.