(64 days)
Not Found
No
The device description is a physiological salt buffer with silica particles, and there is no mention of AI, ML, image processing, or any software-driven analysis.
No
The device is described as a "Physiological salt buffer containing silane-coated, colloid silica particles. For use after appropriate dilution," with an intended use "For gradient sperm separation." This describes a reagent or processing aid for laboratory use, not a device used to treat or diagnose a disease or condition in a human patient.
No
The device is described as a "Physiological salt buffer containing silane-coated, colloid silica particles. For use after appropriate dilution." and its intended use is "For gradient sperm separation." This process is used for sample preparation and enrichment, not for diagnosing a condition or disease.
No
The device description clearly states it is a "Physiological salt buffer containing silane-coated, colloid silica particles," 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 gradient sperm separation." This process is typically performed on biological samples (sperm) in vitro (outside the body) to prepare them for further analysis or procedures.
- Device Description: The device is a "Physiological salt buffer containing silane-coated, colloid silica particles." This is a reagent or solution designed to interact with biological samples in vitro.
- Predicate Device: The predicate device listed is "K991341; ISolate®". A quick search for this predicate device confirms it is an IVD used for sperm separation. The fact that this device is being compared to a known IVD strongly suggests it falls under the same regulatory category.
While the document doesn't explicitly state "In Vitro Diagnostic," the combination of the intended use, device description, and the nature of the predicate device points strongly towards it being an IVD. IVDs are products used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. Sperm separation fits within this scope as it's a preparatory step for procedures like IVF or analysis of sperm quality.
N/A
Intended Use / Indications for Use
- Intended Use: Medium for In Vitro Fertilization Procedures
- Indications for Use: For gradient sperm separation.
Product codes
85 MQL
Device Description
Physiological salt buffer containing silane-coated, colloid silica particles. For use after appropriate dilution.
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)
ISolate® (510(k) # K991341)
Reference Device(s)
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
PREMARKET NOTIFICATION SUMMARY X.
| Submitted by: | Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Nina Arvidsson
Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
| | Mr. Gary L. Yingling
Mr. Michael H. Hinckle
Kirkpatrick & Lockhart, LLP
1800 Massachusetts Avenue, NW
Washington, DC 20036-1800 |
| Date Prepared: | October 07, 2002 |
| Trade Name: | SpermGrad™ |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | ISolate® (510(k) # K991341) |
| Description of the Device: | Physiological salt buffer containing silane-coated,
colloid silica particles. For use after appropriate
dilution. |
| Intended Use: | Medium for In Vitro Fertilization Procedures |
| Indications for Use: | For gradient sperm separation. |
| Technological Characteristics: | The technological characteristics of SpermGrad™
are identical to the predicate device in all material
respects. |
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Nina Arvidsson RA Officer Vitrolife Sweden AB Mölndalsvägen 30 SF-412 63 Gothenburg SWEDEN
Re: K023403
Trade/Device Name: SpermGrad™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II
Product Code: 85 MQL Dated: October 7, 2002 Received: October 10, 2002
Dear Ms. Arvidsson:
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 (PMA), it may be subject to 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 does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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 (OS) 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 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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Snigdon
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 STATEMENT
510(k) Number:
Device Name:
Indications For Use:
SpermGrad™ Assisted Reproduction Media
For gradient sperm separation.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 C.F.R. § 801.109)
()R
( )ver-the Counter Use______
David C. Tilling
(Division Sign-Off)
Division of Reproductive, Abdominal
3 and Radiological Devices
510(k) Number
K123403