(118 days)
Human Serum Albumin (HSA) is intended for those assisted reproductive procedures that require the use of a protein supplement. In particular. HSA is intended for use during in vitro fertilization, during in vitro embryo culture to the desired stage of embryo development, and for the cryopreservation of human embryos.
Human Serum Albumin consists of human serum albumin from therapeutic-grade source material (10mg/mL) in a sterile saline solution.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional for supporting embryonic growth | "Mouse embryo assay confirms product is both functional for its intended use, the support of embryonic growth." |
| Absence of toxic components in formulation | "Mouse embryo assay confirms... that no toxic components are present in the formulation." |
| Meeting criteria outlined in Notice of Final Rule, 63 FR 48428, Docket number 97N-0335 | "Human Serum Albumin is suitable for its intended use, and meet the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335." |
| Sterility (Condition for Release) | "Sterility testing will be performed as a condition of release." |
| Endotoxin Content (Condition for Release) | "Endotoxin testing will be performed as a condition of release." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified directly for the mouse embryo assay. The description mentions "HSA is assayed by mouse embryo assay prior to release to market," implying a continuous testing process rather than a single, fixed test set.
- Data Provenance: The mouse embryo assay is performed in-house by Irvine Scientific as a pre-market release condition. It is a prospective test for each lot produced. The document also mentions "Human Serum Albumin has been used in a variety of clinical settings, for their intended use, for a number of years," suggesting retrospective clinical experience contributes to the overall understanding of its performance, though this isn't a controlled test set in the traditional sense for regulatory submission. The specific country of origin for the mouse embryo assay is not explicitly stated beyond Irvine Scientific's location in Santa Ana, CA, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "ground truth" for the mouse embryo assay is established by the biological outcome of the embryos (growth, absence of toxicity), as evaluated by laboratory personnel following established protocols. No panel of human expert readers is described.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The mouse embryo assay relies on direct biological observation of embryo development. There is no mention of human expert adjudication or resolution of discordant interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No. This device (Human Serum Albumin) is a biological reagent, not an AI or imaging device. Therefore, MRMC studies and the concept of AI assistance for human readers are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is not an algorithm or AI-driven device. Its performance is assessed through biological assays and clinical usage.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Ground Truth: The primary ground truth for the mouse embryo assay is biological outcome/observation (embryo growth and the absence of toxic effects). Additionally, general outcomes data from "a variety of clinical settings" over "a number of years" contributes to the understanding of its real-world performance as a protein supplement. The "Notice of Final Rule" referenced likely provides a regulatory definition or standard for what constitutes acceptable performance in this context.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The "historical information contained in professional literature" and "variety of clinical settings" could be considered analogous to a broad historical "training" or experience base for the product's efficacy, but not a formally defined training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no formal training set for an algorithm. The understanding of the product's effectiveness and safety has been established through years of clinical use and scientific research in the field of assisted reproductive technologies, summarized as "historical information in professional literature" and "clinical settings."
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Irvine Scientific
October 9, 1998
Image /page/0/Picture/3 description: The image shows the logo for Irvine Scientific. The logo consists of a stylized, blocky design that appears to be a combination of the letters 'I' and 'S', enclosed within a square border. Below the logo, the words 'IRVINE SCIENTIFIC' are printed in a simple, sans-serif font.
FEB 8 1999
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: | Human Serum Albumin (HSA) |
|---|---|
| Common Name: | Protein supplement for in vitro embryo culture |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Human Serum Albumin consists of human serum albumin from therapeutic-grade source material (10mg/mL) in a sterile saline solution.
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October 9, 1998
Intended Use:
Human Serum Albumin is intended for use in assisted reproductive procedures that require protein supplementation. These procedures include in vitro fertilization, embryo culture and growth, and embryo cryopreservation.
Technological Characteristics:
Depending upon the procedure used, an appropriate amount of prewarmed, equilibrated HSA is withdrawn, and added to the culture dish and support medium. After the desired stage of embryo development is achieved, the embryo is removed from the culture dish, placed into a HEPES-buffered transfer medium, and implanted into the patient. HSA is not intended to contact the patient.
Performance Data:
HSA is assayed by mouse embryo assay prior to 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. Human Serum Albumin has been used in a variety of clinical settings, for their intended use, for a number of years. In that time, the product has become one of the standard protein supplements used for the in vitro fertilization, growth and cryopreservation 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 performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.
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Conclusion:
The conclusion from performance testing, as well as a review of the historical information contained in professional literature shows that Human Serum Albumin is suitable for its intended use, and meet 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
FEB 8 1999
Ms. Roberta Johnson Manager, Regulatory Affairs Irvine Scientific 2511 Daimler Street Santa Ana, California 92705-5588 Re: K983584 Human Serum Albumin Dated: January 14, 1999 Received: January 19, 1999 Regulatory 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 requlation (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 regult 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 diagnostic devices), please 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 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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Irvine Scientific
ン,
INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number:
Device Name: Human Serum Albumin (HSA)
Indications for Use:
Human Serum Albumin (HSA) is intended for those assisted reproductive procedures that require the use of a protein supplement. In particular. HSA is intended for use during in vitro fertilization, during in vitro embryo culture to the desired stage of embryo development, and for the cryopreservation of human embryos.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use $\underline{ \checkmark }$
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K983584 / 5⁰⁰¹
Human Serum Albumin (HSA)
§ 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.