(92 days)
Sydney IVF Sperm Cryopreservation Buffer is intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing.
Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples.
The provided text describes a 510(k) submission for the Sydney IVF Sperm Cryopreservation Buffer, focusing on demonstrating its substantial equivalence to a predicate device. This submission is for a medical device rather than an algorithm or AI-driven device. As such, many of the requested categories in the prompt, which are typically relevant for AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details), are not directly applicable or discussed in the provided documentation.
However, I can extract the acceptance criteria for the device's performance based on the specific tests mentioned.
Here's an analysis of the provided text in the context of your request:
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| pH Testing | Satisfactory operating performance (specific range not provided) | Passed the requirements of all tests |
| Osmolality Testing | Satisfactory operating performance (specific range not provided) | Passed the requirements of all tests |
| Two-cell Mouse Embryo (MEA) Testing | Satisfactory operating performance (specific outcome not provided, but typically involves embryo development percentage) | Passed the requirements of all tests |
| Bacterial Endotoxin (LAL) Testing | Satisfactory operating performance (specific endotoxin limit not provided) | Passed the requirements of all tests |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified in the provided document. The text states "Sydney IVF Sperm Cryopreservation Buffer was subjected to the following tests," implying that samples of the buffer were tested, but no number of batches or units is given.
- Data Provenance: Not specified. The tests would have been performed by Cook Urological Incorporated or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a chemical buffer, not an AI or diagnostic tool where expert ground truth on data is typically established. The "ground truth" for this device is its physical and biological performance against established scientific and regulatory standards (e.g., pH limits, osmolality ranges, MEA success rates, endotoxin levels), which are determined through laboratory tests.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers or between human readers and AI outputs in diagnostic imaging or similar fields. For a chemical buffer, the "adjudication" is based on the objective results of the lab tests conforming to predefined specifications.
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 medical device (a buffer solution), not an AI algorithm. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The "standalone performance" is the intrinsic performance of the buffer itself as demonstrated by the specified tests.
7. The type of ground truth used
- The "ground truth" for this device's performance is established by objective laboratory test results that meet predefined specifications for pH, osmolality, embryo toxicity (MEA), and endotoxin levels. These specifications are based on regulatory requirements and scientific understanding for medical devices of this type. It's not based on expert consensus, pathology, or outcomes data in the sense typically applied to diagnostic algorithms.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device. The manufacturing process of the buffer is validated, and batches are tested for quality control.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI model, this question is not relevant.
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Traditional 510(k) Submission Sydney IVF Sperm Cryopreservation Buffer COOK UROLOGICAL INCORPORATED 10 May 2006
AUG 1 7 2006
510(k) SUMMARY
Submitted By:
Brenda Davis Regulatory Affairs Technical Writer Cook Urological Incorporated 1100 West Morgan Street Spencer, IN 47460 (812) 829-4891 x 7257 28 April 2006
Device: Trade Name:
Sydney IVF Sperm Cryopreservation Buffer
Proposed Classification Name:
Reproductive Media and Supplements 21 CFR Part 884.6180 (87MQL) Class II
Predicate Devices:
Sydney IVF Sperm Cryopreservation Buffer is comparable to predicate devices described by criteria set forth in the final rule [63 FR 48428].
Device Description
Sydney IVF Sperm Cryopreservation Buffer consists of an aqueous solution intended for use as a buffer to prevent damage to sperm samples during cryopreservation and thawing. The IVF technician will use the buffer to cryopreserve washed spermatozoa, including MESA (microsurgical epididymal sperm aspiration) and TESA (testicular sperm extraction) samples.
Substantial Equivalence
Sydney IVF Sperm Cryopreservation Buffer is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Test Data
Sydney IVF Sperm Cryopreservation Buffer was subjected to the following tests to assure satisfactory operating performance:
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Traditional 510(k) Submission Sydney IVF Sperm Cryopreservation Buffer COOK UROLOGICAL INCORPORATED 10 May 2006
- r pH Testing
- Osmolality Testing "
- Two-cell Mouse Embryo (MEA) Testing 1
- 동 Bacterial Endotoxin (LAL) Testing
The Sydney IVF Sperm Cryopreservation Buffer passed the requirements of all tests. This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 1 7 2006
Ms. Brenda Davis Regulatory Affairs Technical Writer Cook Urological, Inc. 1100 West Morgan Street SPENCER IN 47460
Re: K061371
Trade/Device Name: Sydney IVF Sperm Cryopreservation Buffer Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplement Regulatory Class: II Product Code: MQL Dated: May 10, 2006 Received: May 19, 2006
Dear Ms. Davis:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo with the letters "DA" in the center. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in a stylized font. Three stars are arranged at the bottom of the logo. The logo appears to be a commemorative emblem for a centennial celebration.
Protecting and Promoting Public Health
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ... .
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Traditional 510(k) Submission Sydney IVF Sperm Cryopreservation Buffer COOK UROLOGICAL INCORPORATED 10 May 2006
INDICATIONS FOR USE
510(k) Number (if known): _K06 137 /
Device Name: _Sydney IVF Sperm Cryopreservation Buffer
Sydney IVF Sperm Cryopreservation Buffer is intended for use as Indications for Use: a buffer to prevent damage to sperm samples during cryopreservation and thawing.
Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broaden
Division of Reproduction,
and Radiological Devices
510(k) Number
17.00 I .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
§ 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.