(231 days)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Not Found
No
The document describes a chemical solution (Tyrode's Solution, Acidified) used in assisted reproductive procedures. There is no mention of software, algorithms, or any technology that would incorporate AI or ML. The performance studies focus on chemical properties (pH, endotoxin, sterility) and historical clinical use.
Yes
The device is a solution used in assisted reproductive procedures to manipulate embryos, specifically for zona-drilling, which is a therapeutic intervention aimed at aiding reproduction.
No
The device is a reagent used in assisted reproductive procedures (zona drilling), which is a treatment, not a diagnostic process. It does not identify or determine the presence of a disease or condition.
No
The device description clearly states it is a "synthetic, defined reagent" and a "common cell culture medium," indicating it is a chemical substance, not software.
Based on the provided text, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "assisted reproductive procedures involving the manipulation of embryos" and specifically "zona drilling procedures, for assisted hatching." These procedures are performed in vitro (outside the body) on biological samples (embryos).
- Device Description: It's described as a "synthetic, defined reagent" which is a common characteristic of IVD reagents used in laboratory procedures.
- Performance Studies: The performance studies focus on verifying the properties of the solution itself (pH, endotoxin, sterility) and its historical use in clinical settings for its intended purpose. This aligns with the evaluation of an IVD reagent.
- Predicate Device: The reference to a "Notice of Final Rule" and a Docket number suggests a regulatory context, which is typical for IVD devices.
While the text doesn't explicitly use the term "IVD," the nature of the intended use, the device description, and the context of its evaluation strongly indicate that it falls under the category of an In Vitro Diagnostic device. It's a reagent used in vitro to perform a diagnostic or therapeutic procedure on a biological sample (the embryo).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device 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.
Mentions image processing
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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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
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.
Not Found
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).
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
Irvine Scientific
April 14, 1999 રે જેવ
Image /page/0/Picture/2 description: The image is a black and white logo. The logo is a square with a white design inside. The white design appears to be the letters 'LS' connected together in a stylized way. The letters are thick and blocky, and the overall design is modern and minimalist.
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 hatching |
| procedures | |
| 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
1
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.
2
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.
3
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