(231 days)
Tyrode's Solution, Acidified is intended to be used in zona drilling procedures, for assisted hatching.
Tyrode's Solution, Acidified is intended for use in assisted reproductive procedures involving the manipulation of embryos. Specifically, Tyrode's Solution, Acidified, is intended for use in zona-drilling procedures.
Tyrode's Solution, Acidified is a synthetic, defined reagent with a pH of 2.1 to 2.5. It is based on the formulation of Tyrode's Solution, a common cell culture medium.
This document describes the validation of "Tyrode's Solution, Acidified" for use in zona-drilling procedures, a chemical reagent, not an AI device. Therefore, many of the requested categories related to AI device evaluation (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable.
Here's an analysis of the provided text based on the request, focusing on the information available for a chemical reagent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| pH Level | 2.1 to 2.5 (verified for each newly manufactured lot) |
| Endotoxin Content | Tested prior to release (implicit assumption: must meet specifications) |
| Sterility | Tested prior to release (implicit assumption: must meet specifications) |
| Suitability for Intended Use | Suitable for its intended use (zona-drilling procedures for assisted hatching) |
| Compliance with Regulatory Citeria | Meets criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific testing. Performance data refers to "each newly manufactured lot" being tested for pH, endotoxin, and sterility.
- Data Provenance: Not explicitly stated for specific testing, but implies internal quality control testing for manufactured lots. The document also refers to "historical information contained in professional literature," suggesting external, previously published data or common knowledge about the reagent's use. It has been used in "a variety of clinical settings" for "a number of years."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the product is a chemical reagent. Ground truth is established through chemical and biological assays (pH, endotoxin, sterility) and clinical history of use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a chemical reagent. Performance is determined by meeting predetermined specifications for each manufacturing lot.
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
- Not applicable. This is a chemical reagent, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a chemical reagent, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- pH Level, Endotoxin, Sterility: Ground truth is established by validated laboratory analytical methods and adherence to predefined specification ranges.
- Intended Use Suitability: Ground truth is established through historical clinical use, professional literature, and the product's established optimal pH range for zona drilling. The statement "the product has become the standard reagent used for chemically mediated zona drilling procedures" indicates long-standing clinical acceptance and outcomes.
8. The sample size for the training set
- Not applicable. This is a chemical reagent, not an AI device that undergoes 'training'.
9. How the ground truth for the training set was established
- Not applicable.
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Irvine Scientific
April 14, 1999 રે જેવ
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IRVINE SCIENTIFIC
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
DEC - 6 1999
Submitted by:
Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588
Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Roberta L. Johnson
Date Submitted: April 14, 1999
Device Identification:
| Trade Name: | Tyrode's Solution, Acidified |
|---|---|
| Common Name: | zona-drilling reagent for assisted hatchingprocedures |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Tyrode's Solution, Acidified is a synthetic, defined reagent with a pH of 2.1 to 2.5. It is based on the formulation of Tyrode's Solution, a common cell culture medium.
Tyrode's Solution - Acidified
Page 25 of 30
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April 14, 1999
Intended Use:
Tyrode's Solution, Acidified is intended to be used in zona drilling procedures, for assisted hatching.
Technological Characteristics:
Tyrode's Solution, Acidified has been developed with a pH in the range optimal for use in the assisted hatching procedure referred to as zona drilling. In this procedure, the zona pellucida, a noncellular covering over the fertilized ovum is removed by either a chemical or mechanical "drill". This covering must be removed prior to the implantation of the blastocyst, and subsequent pregnancy. A small amount of Tyrode's Solution, Acidified is applied to the zona pellucida of the embryo with an assisted hatching pipette, the embryo observed under a microscope, and when the desired effect has been achieved, the embryo is washed with a neutral medium prior to implantation or further development in vitro. Zona drilling procedures are commonly performed on embryos from older patients, or those with a history of failed assisted reproductive procedures.
Performance Data:
The pH level of each newly manufactured lot of Tyrode's Solution, Acidified is verified prior to release to market. This parameter is the most important for the proper functioning of the product. Lots that do not meet the release specification are not released for sale. In addition, each lot is tested for endotoxin and sterility prior to release. Tyrode's Solution, Acidified 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 standard reagent used for chemically mediated zona drilling procedures.
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Additional Information:
Endotoxin and sterility testing will be performed as a condition of release for this product. Results of all release assays performed will be reported on a lotspecific certificate of analysis, and will be indicated on the labeling.
Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Tyrode's Solution, Acidified is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 1999
Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street Santa Ana, CA 92705-5588
Re: K991339
Tyrode's Solution Acidified (for zona-drilling procedures) Dated: September 3, 1999 Received September 7, 1999 Requiatory Class: II 21 CFR $884.6180/Procode: 85 MQL
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnosic devices), piease contact the Office of Compliance at (301) 594-4613. 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 CFF 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number:_K99 1339
Device Name:_Tyrode's Solution, Acidified
Indications for Use:
Tyrode's Solution, Acidified is intended for use in assisted reproductive procedures involving the manipulation of embryos. Specifically, Tyrode's Solution, Acidified, is intended for use in zona-drilling procedures.
(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 CFR 801,109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 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.