(187 days)
K 000625, K 000619
K 991279
No
The device description and performance studies focus on the chemical composition and biological efficacy of embryo culture media, with no mention of AI or ML technologies.
No.
The device is a culture medium for embryos used in IVF, which supports embryo development rather than treating a disease or condition.
No
The device description indicates that ISM1+, ISM2+, and UTM+ are "sequential media for the culture and transfer of embryos." Their purpose is to support embryo development, not to diagnose a condition or disease.
No
The device description clearly states that the devices are "sequential media for the culture and transfer of embryos," listing chemical components. This indicates a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the culture and transfer of embryos in the context of IVF and ICSI treatments. This process involves handling biological material (embryos) outside of the body for diagnostic and therapeutic purposes related to fertility.
- Device Description: The device is a set of culture media (ISM1+, ISM2+, UTM+) with specific compositions designed to support the development of embryos. These media are used in vitro (outside the living organism) to facilitate a biological process (embryo development).
- Performance Studies: The performance studies evaluate the effectiveness of the media in supporting embryo development and viability, which are key aspects of in vitro diagnostic procedures in reproductive medicine.
- Predicate Devices: The predicate devices listed (G1.2 media, G2.2 media) are also culture media used in IVF, further supporting the classification of this device as an IVD.
While the device doesn't involve image processing, AI, or specific anatomical sites in the traditional sense of imaging diagnostics, its function as a medium for in vitro embryo culture and transfer firmly places it within the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
ISM1+
For culture of embryos. To be used in culture after fertilization in Universal IVF Medium (K 991279) up to Day3 to 6- to8-cell stage, followed by extended culture in ISM2+ or by transfer in UTM+.
ISM2+
For culture of embryos. To be used in culture from 6- to 8-cell stage on Day3 to blastocyst stage on day 5, followed by transfer in UTM+. ISM2+ shall be used after ISM1+.
UTM+
For transfer of embryos cultured in ISM1+ or ISM2+.
Product codes
85 MQL
Device Description
Medi-Cult's new ISM1+, ISM2+( Innovative Sequential Media) and UTM + (Uterine Transfer Medium) is a modified version of older ISM1/ISM2/UTM media.
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
Medi-Cult's new ISM1+, ISM2+( Innovative Sequential Media) and UTM + (Uterine Transfer Medium) is a modified version of older ISM1/ISM2/UTM media. The original ISM media have been tested in a multicenter trial in France. The study included patients, not more than 40 years of age, accepted for IVF and ICSI treatments to a total of 466 cycles. After fertilization in Universal IVF Medium the embryos were cultured in ISM1, ISM2 and either transferred on Day 2/3 or Day 5 using UTM.The data show that the ISM media support development of viable cleavage and blastocyst embryos following either IVF or ICSI and these can be transferred on Day 2/3 or at the blastocyst stage. All pregnancies in the study were singletons with the exception of one pair of twins. The twins were a result of two individual embryos implanted and therefore no monozygotic twins were seen in the entire study.
Furthermore, a clinical study has been performed where Medi-Cult's original ISM1/ISM2 have been compared to ISM1+/1SM2+. The conclusion was that the two versions were equally effective.
Two prospective studies where the ISM series and ISM+ series respectively have been compared to G1.2/G2.2 media systems have been performed.
Based on the results of these studies it is concluded that Medi-Cult's ISM+ series comprising ISM1+, ISM2+ and UTM+ media are substantial equivalent to Vitrolife's G1,2-G2.2 sequential culture system and is effective for development of embryos for Day 2-3 transfer or for developing blastocysts for Day 5 transfer in patients for IVF or ICSI.
Key Metrics
Not Found
Predicate Device(s)
K 000625, K 000619
Reference Device(s)
K 991279
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 2 0 2003
510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
Indications for use:
ISM1+
For culture of embryos. To be used in culture after fertilization in Universal IVF Medium (K 991279) up to Day3 to 6- to8-cell stage, followed by extended culture in ISM2+ or by transfer in UTM+.
ISM2+
For culture of embryos. To be used in culture from 6- to 8-cell stage on Day3 to blastocyst stage on day 5, followed by transfer in UTM+. ISM2+ shall be used after ISM1+.
UTM+
For transfer of embryos cultured in ISM1+ or ISM2+.
Composition:
ISM1+
- l Physiological salts
- . Sodium bicarbonate
- 이 Penicillin/Streptomycin
- 이 HSA
- Glucose and derived . metabolites
- l Nucleosides
- . Non-essential amino acids
- . Essential amino acids
- Phenol Red .
- I Vitamins
ISM2+
- Physiological salts 트
- 트 Sodium bicarbonate
- Penicillin/Streptomycin 미
- 해 HSA
- 트 Glucose and derived metabolites
- I Nucleosides
- t Non-essential amino acids
- 트 Essential amino acids
- l Phenol Red
- Vitamins .
UTM+
- 트 Physiological salts
- l Sodium bicarbonate
- . Penicillin/Streptomycin
- 트 HSA
- Glucose and derived metabolites
- 비 Nucleosides
- 피 Non-essential amino acids
- 에 Essential amino acids
- 이 Phenol Red
- l Vitamins
- I Hyaluronate
Stability, cytotoxicity- and biocompatibility testing
Stability testing of ISM1+/ ISM2+/UTM+ sequential media has been performed for 17 weeks and a shelf life of 8 weeks from shipment date is recommended. Once opened the product is to be used within 28 days.
Furthermore UTM+ was classified as non-toxic according to the Mouse Embryo test, non-irritant according to vaginal irritation test and showed no evidence of delayed contact hypersensitivity.
Product testing controls
-
- Sterility
-
- pH
-
- Osmolality
-
- Endotoxin ≤ 0.1 EU/ml
- Mouse Embryo Assay, ISM1+ and ISM2+ (one cell assay, Blastocyst rate > 70 %), UTM+ ( two న్ cell assay, blastocyst rate > 80 %)
For each batch a Certificate of Analysis with the results of the above tests is available.
1
Clinical Documentation:
Medi-Cult's new ISM1+, ISM2+( Innovative Sequential Media) and UTM + (Uterine Transfer Medium) is a modified version of older ISM1/ISM2/UTM media.
The original ISM media have been tested in a multicenter trial in France. The study included patients, not more than 40 years of age, accepted for IVF and ICSI treatments to a total of 466 cycles. After fertilization in Universal IVF Medium the embryos were cultured in ISM1, ISM2 and either transferred on Day 2/3 or Day 5 using UTM.The data show that the ISM media support development of viable cleavage and blastocyst embryos following either IVF or ICSI and these can be transferred on Day 2/3 or at the blastocyst stage.
All pregnancies in the study were singletons with the exception of one pair of twins. The twins were a result of two individual embryos implanted and therefore no monozygotic twins were seen in the entire study.
Furthermore, a clinical study has been performed where Medi-Cult's original ISM1/ISM2 have been compared to ISM1+/1SM2+. The conclusion was that the two versions were equally effective.
Two prospective studies where the ISM series and ISM+ series respectively have been compared to G1.2/G2.2 media systems have been performed.
Based on the results of these studies it is concluded that Medi-Cult's ISM+ series comprising ISM1+, ISM2+ and UTM+ media are substantial equivalent to Vitrolife's G1,2-G2.2 sequential culture system and is effective for development of embryos for Day 2-3 transfer or for developing blastocysts for Day 5 transfer in patients for IVF or ICSI
During our studies there has been no registered complaints and no evidence that the product has been the cause of any serious adverse events in connection with its intended use.
Thus based on the clinical data presented and our experience with the ISM products we feel that the safety and effectiveness of the product for its intended use is shown in the present submission and the products are substantially equivalent to the predicated devices G1.2 media ( K 000625) and G2.2 media ( K 000619).
Prepared and Submitted by:
forther
02-/53-23
Date
Ronald G. Leonardi, Ph.D. President R & R REGISTRATIONS P.O. Box 262069 San Diego, Ca 92131 619-586-0751
accella
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is facing to the left. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
AUG 2 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medi-Cult a/s % Ronald G. Leonardi, Ph.D. President R & R Registrations P.O. Box 262069 SAN DIEGO CA 92196-2069 Re: K030490
Trade/Device Name: Innovative Sequential Media System (ISM1"", ISM2"") and Uterine Transfer Medium (UTM"") Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: June 11, 2003 Received: June 11, 2003
Dear Dr. Leonardi:
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 (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.
3
Page 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 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known)
K030490
Device Name: ISM1+™, ISM2+™ and UTM+™
INDICATIONS FOR USE:
ISMI+
For culture of embryos. To be used in culture after fertilization in Universal IVF Medium (K 991279) up to Day 3 to 6- to 8-cell stage, followed by extended culture in ISM2+ or by transfer in UTM+.
ISM2+
For culture of embryos. To be used in culture from 6- to 8-cell stage on Day 3 to blastocyst stage on Day 5, followed by transfer in UTM+. ISM2+ shall be used after ISM1+.
UTM+ For transfer of embryos cultured in ISM1+ or ISM2+.
(PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
David A. Lessem
(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K030490
iii