(148 days)
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No
The description focuses on the chemical composition and biological function of a culture medium, with no mention of AI or ML.
No
The device is a culture medium used for in vitro fertilization and embryo development, not a device that directly treats a medical condition in a patient.
No
Explanation: The device is a culture medium used for in vitro fertilization and embryo development, not for diagnosing a condition or disease. It is assayed to ensure its functionality in supporting embryonic growth.
No
The device description clearly states it is a "synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances," which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "assisted reproductive procedures which include gamete and embryo manipulation" and used as a "culture medium from fertilization through day 5/6 of embryo development in vitro." This involves manipulating and culturing human biological material (gametes and embryos) outside the body for diagnostic or therapeutic purposes related to reproduction.
- Device Description: The description reinforces its use in "fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro." This is a classic application of an IVD in the context of assisted reproduction.
- Performance Studies: The mention of a "mouse embryo assay" to assure functionality and lack of toxicity for supporting embryonic growth further indicates its role in evaluating the viability and development of embryos, which is a diagnostic aspect of assisted reproduction.
- Predicate Devices: The listed predicate devices (MultiBlast Medium and global®) are also culture media used in assisted reproductive technologies, which are typically classified as IVDs.
While the document doesn't explicitly use the term "diagnostic," the function of supporting and evaluating the development of embryos in vitro for the purpose of assisted reproduction falls squarely within the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.
Product codes
MOL
Device Description
Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to be used during fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Single Step Medium is assayed by mouse embryo assay prior to release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth, and that no toxic components are present in the formulation: MultiBlast Medium (K034063) has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become the one of the standard media used as the second, more complex stage of a sequential media protocol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
K072609
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
Submitted by: Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588
Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Wendell Lee
Date Submitted: September 14, 2007
Device Identification:
| Trade Name: | Single Step Medium |
|---|---|
| Common Name: | In vitro embryo culture medium |
| Classification Name: | Reproductive Media (21 CFR, 884.6180) |
Predicate Device:
Final Rule, 63 FR 48428, Docket number 97N-0335 MultiBlast Medium (K034063) global®: fertilization, embryo culture and transfer medium (K053552)
Description:
Single Step Medium is a synthetic, defined medium, composed of a balance mixture of salts, amino acids, minerals and other nutrient substances designed to be used during fertilization and culture of zygote/embryo through the desired development stage (up to 5/6 days) in vitro.
1
Intended Use:
Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.
Technological Characteristics:
After allowing the fertilized zygote to develop in vitro in Single Step Medium, the embryo is removed from the culture dish. It is placed into a fresh dish containing Single Step Medium, and protein supplementation. The dish is then returned to the incubator, and the embryo is allowed to continue develop in vitro. The media is replenished after forty-eight (48) hours with fresh media and the embryo is further incubated until the desired stage of development has been achieved (up to 5/6 days) in vitro. After the desired stage of development is obtained the embryo is implanted into the patient.
Performance Data:
Single Step Medium is assayed by mouse embryo assay prior to release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth, and that no toxic components are present in the formulation: MultiBlast Medium (K034063) has been used in a variety of clinical settings, for its intended use, for a number of years. In that time, the product has become the one of the standard media used as the second, more complex stage of a sequential media protocol.
Additional Information:
Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.
2
Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature in addition to the comparison to the predicate devices show that Single Step Medium is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335. References are presented in Appendix F.
| Product Name | K # | Fertilization
Medium | Culture of
Embryos
from
Day 3 to 5/6 | Culture of
Embryos
up to
Day 5/6 | Transfer
Medium |
|------------------------------------------------------------------------|---------|-------------------------|-----------------------------------------------|-------------------------------------------|--------------------|
| Single Step
Medium | K072609 | ✓ | | ✓ | |
| MultiBlast Medium | K034063 | | ✓ | | |
| global®:
fertilization,
embryo culture
and transfer
medium | K053552 | ✓ | | ✓ | ✓ |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
FEB 1 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wendell Lee, Pharm.D. Vice President, Regulatory Affairs/Ouality Systems Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588
Re: K072609
Trade/Device Name: Single Step Medium Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: MOL Dated: January 28, 2008 Received: January 29, 2008
Dear Dr. Lee:
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 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.
4
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.
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 Center for Devices and Radiological Health's (CDRH's) 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 notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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
5
Irvine Scientific
INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number: KO7 2609
Device Name: Single Step Medium
Indications for Use:
Single Step Medium is intended for use in assisted reproductive procedures which include gamete and embryo manipulation. These procedures include the use of Single Step Medium as a culture medium from fertilization through day 5/6 of embryo development in vitro.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Janair Brigdon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices
510(k) Number
Page 1 of
Single Step Medium