(98 days)
Not Found
No
The device descriptions and intended uses are for laboratory reagents and media used in assisted reproduction procedures. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The devices (Oil For Tissue Culture, Gradient System, SpermFreeze) are used for in-vitro fertilization procedures, sperm separation, purification, and cryopreservation, which are supportive laboratory procedures rather than directly therapeutic interventions on a patient.
No
The provided text describes products used for tissue culture, sperm separation and purification, and sperm cryopreservation in assisted reproduction procedures. These are laboratory reagents and media, not devices that diagnose medical conditions.
No
The device description clearly states the devices are liquids and solutions, which are physical substances, not software.
Based on the provided information, yes, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended uses clearly describe procedures performed in vitro (outside the living body) on biological samples (tissue culture, human sperm) for the purpose of assisted reproduction. This aligns with the definition of an IVD.
- Device Description: The descriptions detail the composition of the substances used in these in vitro procedures.
- Predicate Devices: The listed predicate devices (K011462, K030116, K030117) are all products used in assisted reproductive technology and are classified as IVDs by the FDA. This further supports the classification of these devices as IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the combination of the intended use, device description, and the nature of the predicate devices strongly indicates that these products fall under the category of IVDs.
N/A
Intended Use / Indications for Use
Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
Product codes
MQL
Device Description
Oil For Tissue Culture is a colorless liquid paraffin.
Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%.
SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.
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)
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
Premarket Notification ~ FertiPro Reproductive Media Bundle
MAR 2 3 2006
Image /page/0/Picture/2 description: The image shows the text "5. 510(k) Summary" at the top left. To the right of this text is an image of a baby. Further to the right is the text "FertiPro N.V."
Industriepark Noord 32 - 8730 Beemem - Belgium - Tel +32 50 79 18 05 - Fax +32 50 79 17 99
Submitter's name: Address:
Phone: Fax number:
Name of contact person:
FertiPro N.V. Industriepark Noord 32 Beernem West-Vlaanderen, Belgium 8730 +32 50 79 18 05 +32 50 79 17 99
Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821 Email: grace@regulatoryspecialists.com
Date the summary was prepared: December 13, 2005
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Name of the device: Trade or proprietary name: Common or usual name: Classification name:
Oil for Tissue Culture Oil for Tissue Culture Mineral Oil Reproductive media
Gradient System Sil-Select Plus Gradient System Reproductive media
SpermFreeze SpermFreeze SpermFreeze Reproductive media
Page 14
1
K.J.5.544
Page 2 of 5
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| Device | Ref# | Decided |
|---|---|---|
| OIL FOR TISSUE CULTURE | K011462 | 06/13/2001 |
| ENHANCE-S PLUS H | K030116 | 02/12/2003 |
| ENHANCE SPERM FREEZE | K030117 | 03/20/2003 |
Description of the devices:
Oil For Tissue Culture is a colorless liquid paraffin.
Gradient System is a solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%.
SpermFreeze is a HEPES buffered freezing medium for use with human Sperm. It contains 0.4 % human serum albumin.
Indications:
Oil For Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
Gradient System is used for separation and purification of human sperm for assisted reproduction procedures.
SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
Summary of the technological characteristics of our device compared to the predicate device:
The predicates and these devices were compared in the following areas and found to have exact technological characteristics and to be equivalent.
Formula Special controls Packaging Performance Testing
2
Image /page/2/Picture/1 description: The image is a black and white logo. The logo is circular and contains an image of a bird in flight. The bird is stylized and has three lines representing its body. The text "NATIONAL INSTITUTE OF JUSTICE - OJJDP" is written around the perimeter of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2006
FertiPro N.V. % Ms. Grace Holland Regulatory Specialist Regulatory Specialist, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K053494
Trade/Device Name: Oil for Tissue Culture, Gradient System, and SpermFreeze Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MQL Dated: February 22, 2006 Received: February 24, 2006
Dear Ms. Holland:
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 the cholobals) to regary many date of the Medical Device Amendments, or to devices that have been May 20, 1778, no 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 do not require approvisions of the Act. 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 n your as , 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 FI)A has made a determination that your device complies with other requirements of the Act or any Foderal states 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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FIXA 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 11 you don't the Office of Compliance at one of the following numbers, based on the regulation number 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 notific.umn" ( 1 CFR 807.97). You may obtain other general information on your responsibilities under the Ave institution Division of Small Manufacturers, International and Consumer Assistance at its toll-free mimber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Namev C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement Indications for Use
510(k) Number (if known): K053494
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications.for Use:
Oil For Tissue Culture is used in covering tissue culture in in-vitro Off of the more of the end micromanipulative procedures such as ICSI and assisted hatching.
x AND/OR Over-The-Counter Use _ Prescription Use _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (FLLASE DO NOT WARTE BEEGH THES CANS CHE CA
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division: Criminal
Page 1 of _3
Division
Division: Laparoscopic abdominal,
and Robotic devices
510(k) Number K053494
5
Indications for Use
510(k) Number (if known): K053494
Device Name: Gradient System
Indications for Use:
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
× AND/OR Over-The-Counter Use _ Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (FLEASE DO NOT MATE BECON THIS END COMPORT CONSULTION ------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tlan curic Brixton
Division Sign Off
Page 2 of 3
productive, Abdominal, and Radiological Devi 510(k) Number
6
Premarket Notification - FertiPro Reproductive Media Bundle
Indications for Use
510(k) Number (if known): K053494
Device Name: SpermFreeze
Indications for Use:
SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
AND/OR Over-The-Counter Use _ × Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (PLEASE DO NOT WRITE BELOW THIS CIRE CONTINGS CHANAS CANNER ------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broadlon
Page 3 of _3
(Division Sign-Off))
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053494