(64 days)
Not Found
No
The device description and lack of mentions of AI/ML terms indicate it is a chemical solution for sperm handling, not a software or hardware device incorporating AI/ML.
No
The device is a handling solution used for sperm immobilization and isolation prior to ICSI, which is a laboratory procedure, not a therapeutic intervention on a patient. It assists in a procedure but does not directly treat a disease or condition in a patient.
No
The device is a "sperm handling solution" for immobilization and isolation of sperm prior to ICSI. Its function is to prepare a biological sample, not to diagnose a condition.
No
The device description explicitly states it is a "Viscous sperm handling solution," which is a physical substance, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the immobilization and isolation of sperm prior to intracytoplasmic sperm injection, ICSI". This process is performed in vitro (outside the body) on biological samples (sperm).
- Device Description: The device is a "Viscous sperm handling solution". This is a reagent or solution used in a laboratory setting for manipulating biological samples.
- Predicate Device: The predicate device listed is "K991343 PVP-Polyvinylpyrrolidone device". Looking up this K number would likely confirm it is also an IVD used in assisted reproductive technology procedures.
IVDs are defined as 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. While this device isn't directly diagnosing a disease, it is used in a process (ICSI) that is part of the treatment for infertility, which is considered a medical condition. The manipulation of sperm in vitro for this purpose falls under the scope of IVDs.
N/A
Intended Use / Indications for Use
Intended Use: Medium for In Vitro Fertilization Procedures
Indications for Use: For the immobilization and isolation of sperm prior to intracytoplasmic sperm injection, ICSI.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Viscous sperm handling solution. Ready-to-use after equilibration at 15-25°C.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K43116
JAN 1 3 2005
X. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden AB
Faktorvägen 13
SE-434 37 Kungsbacka
SWEDEN |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Morgan Hugosson
Vitrolife Sweden AB
Faktorvägen 13
SE-434 37 Kungsbacka
SWEDEN |
| Date Prepared: | November 1, 2004 |
| Trade Name: | ICSITM |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | PVP-Polyvinylpyrrolidone device (K991343) |
| Description of the Device: | Viscous sperm handling solution. Ready-to-use after
equilibration at 15-25°C. |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Indications for Use: | For the immobilization and isolation of sperm prior to
intracytoplasmic sperm injection, ICSI. |
| Technological Characteristics: | The technological characteristics of ICSITM are
essentially similar to those of the predicate device.
None of these changes raise new questions of safety or
effectiveness. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure with three curved lines representing its wings or body. The logo is black and white.
Public Health Service
JAN 1 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Morgan Hugosson Regulatory Affairs Officer Vitrolife Sweden AB Faktorvägen 13 SE-434 37 Kungsbacka SWEDEN
Re: K043116 Trade/Device Name: ICSI™, Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II - - -Product Code: 85 MQL Dated: November 1, 2004 Received: November 26, 2004
Dear Mr. Hugosson:
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 street in the enclosure) to legally marketed predicate devices marketed in interstate commons on use a 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, cor (rice) 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 provisions of uts Aug. 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.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act any Federal statutes and regulations administered by other Federal agencies. You must comply with the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, permits a vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation pumber at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
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
3
Indications for Use
510(k) Number (if known): K043116
Device Name: ICSI™ Assisted Reproduction Media
Indications For Use: For the immobilization and isolation of sperm prior to intracytoplasmic sperm injection, ICSI
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Maneye Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number [K043116](https://510k.innolitics.com/search/K043116)
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