(156 days)
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No
The summary contains no mention of AI, ML, image processing, or any related concepts, and the intended use is a standard laboratory procedure.
No
The device is described for "in vitro procedures involving sperm separation, washing and isolation," which are laboratory procedures and do not directly treat a patient.
No
The device, PureCeption™, is described as being "for in vitro procedures involving sperm separation, washing and isolation." These are preparatory or processing steps for samples and do not involve diagnosing a condition in a patient.
No
The provided text describes a device for in vitro sperm procedures, which inherently involves physical components and processes, not just software. The lack of a device description further prevents confirmation of a software-only nature.
Based on the provided information, specifically the "Intended Use / Indications for Use" statement:
"PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation."
This statement clearly indicates that the device is intended for use on biological samples (sperm) outside of the living body ("in vitro"). Procedures involving the manipulation and preparation of biological samples for diagnostic or therapeutic purposes are characteristic of In Vitro Diagnostic (IVD) devices.
Therefore, based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
N/A
Intended Use / Indications for Use
PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
SEP 2 4 1999
Pacific Andrology, Inc. c/o Mr. Greg Holland Regulatory Consultant Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K991381
PureCeption™ Lower Phase, PureCeption™ Upper Phase, and PureCeption™ Sperm Washing Media with HEPES-buffered Ham's F-10 and HSA Dated: August 20, 1999 Received: August 23, 1999 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Mr. Holland:
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 indude 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 dass III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Eederal 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.
lf 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 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
1
Premarket Notification - Pacific Andrology, Inc. - Sperm Isolation Medium
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_K991381
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
PureCeption™ is for in vitro procedures involving sperm separation, washing and isolation.
(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) | |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991381 |
|---|---|
| --------------- | --------- |