(80 days)
Dulbecco's Phosphate Buffered Saline Solution (PBS 1X) is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, PBS 1X is intended for use as a spermprocessing medium in washing procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo.
PBS 1X is a defined mixture of salts in a physiologic buffer designed to be used as an oocyte retrieval medium, for the short term "bench-top" maintenance of oocytes prior to manipulation, and for the transport of fertilized embryos during implantation procedures.
This document describes the acceptance criteria and the study for a medical device called "PBS 1X," a Dulbecco's Phosphate Buffered Saline Solution, designed for use in assisted reproductive technology (ART) procedures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional for intended use: Support of embryonic growth (as required by predicate device and 21 CFR 886.6180) | "PBS 1X is assayed by mouse embryo assay prior to its release to market. This assay assures that the product is both functional for its intended use, the support of embryonic growth..." |
| Absence of toxic components: (as required by predicate device and 21 CFR 886.6180) | "...and that no toxic components are present in the formulation." |
| Meets criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | "The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that PBS 1X is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
| Sterility (condition of release) | "Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing." |
| Endotoxin levels (condition of release) | "Mouse embryo testing will be performed as a condition of release for this product, as well as endotoxin and sterility testing." |
| Historical Clinical Performance as a "standard media" (implied acceptance based on historical use and predicate) | "PBS 1X 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 one of the standard media used for the retrieval, maintenance and transport of human gametes and embryos." (This point doesn't specify a numerical acceptance criterion but rather the device's established efficacy and safety in practice, which supports the claim of meeting general requirements for reproductive media.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the mouse embryo assay test set or its provenance (e.g., country of origin). It mentions "mouse embryo assay" implying a biological test, but specific numbers are not provided. The phrase "PBS 1X has been used in a variety of clinical settings... for a number of years" suggests a retrospective review of real-world clinical usage, but no specific data or sample sizes from these clinical settings are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the mouse embryo assay. It states that "mouse embryo assay" is performed, implying a standard laboratory procedure, but does not detail the personnel involved in interpreting results or establishing the "truth" of embryonic growth or toxicity. For the historical clinical data, no experts are cited as establishing a ground truth for a discrete test set; rather, it refers to the product's long-term use and acceptance within the "professional literature."
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1) for the test set. The mouse embryo assay appears to be a laboratory test with outcome measures (embryonic growth, toxicity), rather than a subjective assessment requiring multi-reader adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No MRMC comparative effectiveness study is mentioned, nor is there any discussion of human reader improvement with or without AI assistance. This device is a biological solution, not an AI or imaging diagnostic tool that would typically involve an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. PBS 1X is a biological solution, not an algorithm, and therefore does not have a standalone algorithm-only performance to assess.
7. The Type of Ground Truth Used
The primary ground truth for the device's performance relies on:
- Biological Outcome Data: The "mouse embryo assay" directly assesses the product's ability to support embryonic growth and the absence of toxic components.
- Regulatory Compliance: Meeting the criteria outlined in the "Notice of Final Rule, 63 FR 48428, Docket number 97N-0335" serves as a regulatory ground truth.
- Historical Clinical Acceptance: The fact that it "has become one of the standard media used" and has been used in "a variety of clinical settings, for its intended use, for a number of years" implies a form of "community consensus" or established clinical efficacy and safety as a ground truth.
8. The Sample Size for the Training Set
This question is not applicable because PBS 1X is a biological product and not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above; there is no training set for this type of device.
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Irvine Scientific
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IRVINE SCIENTIFIC 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: Roberta L. Johnson
Date Submitted: October 9, 1998
Device Identification:
| Trade Name: | PBS 1X |
|---|---|
| Common Name: | Dulbecco's Phosphate Buffered Saline Solution |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
PBS 1X is a defined mixture of salts in a physiologic buffer designed to be used as an oocyte retrieval medium, for the short term "bench-top" maintenance of oocytes prior to manipulation, and for the transport of fertilized embryos during implantation procedures.
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April 16, 1999
Intended Use:
PBS 1X is intended for use in assisted reproductive procedures that involve the manipulation, retrieval and transfer of gametes and embryos. These procedures include oocyte retrieval, short term oocyte maintenance and transfer of fertilized embryos during implantation.
Technological Characteristics:
Mature oocytes may be retrieved from the patient by flushing the patient's reproductive system with PBS 1X. The occytes may then be maintained for short periods of time in PBS 1X prior to assisted reproductive technology procedures, such as in vitro fertilization and ICSI. After fertilization, the embryo is then transferred to an appropriate culture and support medium for development in vitro. Once the desired stage of development has been achieved, usually three days post fertilization, the embryo is placed into fresh PBS 1X and transferred to the patient's uterus for implantation and development.
Performance Data:
PBS 1X is assayed by mouse embryo assay prior to its 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. PBS 1X 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 one of the standard media used for the retrieval, maintenance and transport of human gametes and embryos.
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
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performed will be reported on a lot-specific 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 PBS 1X 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 Cornorate Boulevard Rockville MD 20850
JUL - 8 1999
Ms. Roberta Johnson Manager, Regulatory Affairs Irvine Scientific. Inc. 2511 Daimler Street Santa Ana, CA 92705
Re: K991342 PBS 1X. Dulbecco's Buffered Saline Solution Dated: April 16, 1999 Received: April 19, 1999 Requlatory 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 (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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiiance 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 CFR 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: | K991342 |
|---|---|
| Device Name: | PBX IX |
Indications for Use:
Dulbecco's Phosphate Buffered Saline Solution (PBS 1X) is intended for use in assisted reproductive technology procedures that involve the manipulation of gametes or embryos. Specifically, PBS 1X is intended for use as a spermprocessing medium in washing procedures, as an oocyte retrieval medium, for transport of the embryo, and as a support medium for implantation of the embryo.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K991342 |
| Prescription Use | / |
|---|---|
| (Per 21 CFR 801.109) |
§ 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.