(328 days)
For drilling of the zona pellucida.
Acidified Tyrodes Solution is a ready-to-use product with a pH between 2.3 and 2.5 for zona perforation.
Here's a breakdown of the acceptance criteria and study information for Medi-Cult Acidified Tyrodes Solution, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Product Properties | pH | Between 2.3 and 2.5 |
| Quality Control | Bioburden | Production-test (passed, implied) |
| Integrity filter | Production-test (passed, implied) | |
| Sterility | QC-test (passed, implied) | |
| pH | QC-test (matched specification, implied) | |
| Clinical Performance | Safety | No registered complaints, no evidence of serious adverse events in the last 1.5 years |
| Effectiveness | Routinely used for zona pellucida perforation, specific clinical testing cited |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a distinct "test set" in the context of a controlled trial with a defined number of cases. The clinical support comes from established use and a published study.
- Data Provenance: The text mentions:
- "initial clinical testing of Medi-Cult acidified Tyrodes has been done by Dr. Alan Handyside, Dept. Of Obstetrics and Gynecology, St. Thomas' Hospital, Londn, UK and by Søren Ziebe, the National Hospital, Copenhagen, Denmarke." This implies prospective clinical observation/use.
- "The culture media from Medi-Cult have been used by many European IVF-units since the end of the 1980'ties." This suggests a long history of retrospective use data.
- One specific publication is cited: "Søren Ziebe, Anders Nyboe Andersen, Anne-Grethe Andersen, Anne Lis Mikkelsen and Svend Lindenberg. Results of intracytoplasmic sperm injection in relation to indication Acta Obstetricia et Gynecological Scandinavica 1997; 335-339." This is a prospective clinical study, though the specific number of cases utilizing the Medi-Cult solution solely is not broken out.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this device and its submission. The product is a chemical solution for a specific mechanical action (zona drilling). "Ground truth" in this context would likely refer to the physical effect of the solution (e.g., successful zona perforation) and the subsequent clinical outcomes (e.g., fertilization rates, pregnancy rates). Experts involved would be the clinicians performing the IVF procedures using the solution. The text cites:
- Dr. Alan Handyside, Dept. Of Obstetrics and Gynecology, St. Thomas' Hospital, London, UK.
- Søren Ziebe, the National Hospital, Copenhagen, Denmark.
- Other unnamed "many European IVF-units."
Their qualifications are implied by their roles in Obstetrics and Gynecology departments and IVF units, indicating expertise in reproductive medicine.
4. Adjudication Method for the Test Set
This is not applicable as there's no mention of a formal adjudication process for a "test set" in the context of expert review for image-based or diagnostic device performance. The assessment is based on clinical outcomes and the absence of adverse events.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This device is a chemical solution, not an AI-powered diagnostic or interpretive tool. Therefore, a MRMC study comparing human reader performance with or without AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. As a chemical solution, there is no "algorithm" or standalone "performance" in the sense of an AI or software device. The device's function is purely chemical/physical.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's effectiveness relies on:
- Clinical Outcomes Data: Successful zona drilling (implied by routine use), subsequent fertilization, and embryo development (implied by the clinical study reference). The stated indication is "For drilling of the zona pellucida."
- Absence of Adverse Events: This serves as ground truth for safety.
- Published Data: The product is "based on published data" regarding acidified Tyrodes solution for zona perforation.
8. The Sample Size for the Training Set
This is not applicable. This device is a chemical solution, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above (no training set).
{0}------------------------------------------------
Medi ~Cult
510(k) Summary Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination (K991470)
The product: "Medi-Cult Acidified Tyrodes Solution" Cat.No. 1060 -
Indications for use: For drilling of the zona pellucida.
("Medi-Cult Acidified Tyrodes Solution" has for many years been used to chemically etch (drill) holes in the zona pellucida. The low pH of the solution will dissolve the polymers constituting the zona pellucida).
Product formulation:
- Potassium Chloride
- Calcium Chloride
- Magnesium Chloride
- Sodium Phosphate Monobasic
- Glucose
- Povidone K-90, polyvinylpyrrolidone
- Sodium Chloride
Product testing control contents:
- Bioburden, production-test -
- Integrity filter testing, production-test -
- ﯿ Sterility, QC-test
- pH, QC-test -
The culture media from Medi-Cult have been used by many European IVF-units since the end of the 1980'ties. (Produced and distributed by GEA-Biotech 1987 to 1989 and by Medi-Cult a/s from 1989). The Medi-Cult media were at that time introduced as a replacement for in-house prepared culture media.
Zona drilling has been performed to facilitate hatching (assisted hatching). Acidified Tyrodes solution has been routinely used for chemically etching a whole (drilling) in the zona pellucida. Medi-Cult produces an acidified Tyrodes solution based on published data. The product has been designed especially for IVF procedures for zona pellucida perforation. Acidified Tyrodes Solution is a ready-to-use product with a pH between 2.3 and 2.5 for zona perforation.
Revised 3/1/2000 K991470 2/16/2000
{1}------------------------------------------------
Medi ~ Cult
The initial clinical testing of Medi-Cult acidified Tyrodes has been done by Dr. Alan Handyside, Dept. Of Obstetrics and Gynecology, St. Thomas' Hospital, Londn, UK and by Søren Ziebe, the National Hospital, Copenhagen, Denmarke (Søren Ziebe, Anders Nyboe Andersen, Anne-Grethe Andersen, Anne Lis Mikkelsen and Svend Lindenberg. Results of intracytoplasmic sperm injection in relation to indication Acta Obstetricia et Gynecological Scandinavica 1997; 335-339.)
There have been no registered compliants on the product and no evidence in the last 1.5 year that the product has been the cause of any serious adverse events in connection with its intended use.
Thus based on the Federal Register Notice (Final Rule, Vol. 63, No. 175, page 48429, September 1 , 1998), "Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In-Vitro Fertilization and Related Assisted Reproduction Procedures" effective on October 13 , 1998 and the supportive clinical data we feel that the safety and effectiveness of the products for its intented use is shown in the present submission.
Prepared and Submitted by:
Orm M. Slew for March 1, 2000
Ronald G. Leonardi. Ph. D. President R & R Registrations P.O. Box 262069 San Diego CA 92196 858-586-0751
Date
Revised 3/1/2000
K991470 2/16/2000
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 7 2000
Medi-Cult A/S c/o Ronald G. Leonardi, Ph.D. President R & R Registrations 9915 Cam. Chirimolla San Diego, CA 92131
Re: K991470 Medi-Cult Acidified Tyrodes Solution - Medium Dated: February 18, 2000 Received: February 22, 2000 Requiatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Dr. Leonardi:
We have reviewed vour Section 510k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices markeled 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 Cosmelic Act (Act, 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 III (Premarket Approval), it may be subject to such additional controis . Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requiration (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you micht have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or requlations.
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 predication 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{3}------------------------------------------------
510(k) Number (if known) K991470
Medi-Cult Acidified Tyrodes Solution Device Name:
Indications for Use:
For drilling of zona pellucida
(PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David L. Symm
Division Sign-Off Division of Reproductive, Abdominal, EN and Radiological Devi 510(k) Number.
§ 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.