(334 days)
63 FR 48428, September 10, 1998
Not Found
No
The device description and intended use focus on a chemical solution (PVP) for sperm immobilization, with no mention of AI/ML, image processing, or data-driven algorithms.
No.
The device is used to aid in the immobilization and isolation of sperm cells for ICSI procedures, which is a preparatory step for a medical procedure rather than a direct treatment of a disease or condition. Its function is to facilitate the handling of sperm, not to therapeutically act on a patient's body or disease.
No
Explanation: The device is intended to aid in the immobilization and isolation of sperm cells for ICSI procedures, which is a preparation step for a medical procedure, not a diagnostic one. It does not provide information about a patient's health status or disease.
No
The device is a physical solution (aqueous solution containing 10% polyvinylpyrrolidone) provided in glass vials, not a software program.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures." ICSI is a laboratory procedure performed on biological samples (sperm cells) outside of the body to aid in fertilization.
- Device Description: The device is an "aqueous solution containing 10% polyvinylpyrrolidone (PVP)" used to "reduce the motility of sperm and make it easier to collect them with an ICSI Pipette." This describes a reagent or medium used in a laboratory setting to prepare biological samples for a diagnostic or therapeutic procedure.
- Predicate Device: The mention of a predicate device with a reference to the Federal Register (63 FR 48428) suggests that this device is being compared to a previously cleared or regulated device, which is common for IVDs.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device is used in a procedure (ICSI) that is part of assisted reproductive technology, the preparation and handling of the sperm cells using this medium are performed in vitro (outside the body) and are crucial steps in the overall process.
Therefore, the Sydney IVF™ PVP fits the definition of an IVD because it is a reagent used in vitro to prepare biological samples for a procedure related to reproductive health.
N/A
Intended Use / Indications for Use
Sydney IVF™ PVP consists of a sperm medium containing 10% oyunoy in the reserved is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Sydney IVE™ PVP is an aqueous solution containing 10% polyvinylpyrrolidone (PVP), and is used to reduce the motility of sperm and make it easier to collect them with an ICSI Pipette. Sydney IVF™ PVP is provided in glass vials with FluroTech-coated stoppers available in 200 µL fill volumes.
Mentions image processing
Not Found
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)
Sydney IVF™ PVP was subjected to testing to assure biocompatibility and satisfactory operating performance. Sydney IVF™ PVP passed the requirements of all tests.
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.
63 FR 48428, September 10, 1998
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
510(k) Summary as Required by Section 807.92(a)
| Submitted By: | COOK OB/GYN TM
Regulatory Affairs
1100 West Morgan Street
Spencer, Indiana, 47460 |
|-----------------|--------------------------------------------------------------------------------------------|
| Telephone: | 812-829-6500 |
| Facsimile: | 812-829-2022 |
| Contact: | Brenda Davis |
| Date Submitted: | April 8, 2003 |
Names of Device:
| Trade Name: | Sydney IVF™ PVP |
|---|---|
| Common/Usual Name: | Sperm Immobilization Medium |
| Classification Name: | Reproductive media and supplements |
| 21 CFR, 884.6180 (85MQL) | |
| Predicate Device: | 63 FR 48428, September 10, 1998 |
Device Description:
Sydney IVE™ PVP is an aqueous solution containing 10% polyvinylpyrrolidone (PVP), and is used to reduce the motility of sperm and make it easier to collect them with an ICSI Pipette. Sydney IVF™ PVP is provided in glass vials with FluroTech-coated stoppers available in 200 µL fill volumes.
Intended Use:
Sydney IVF™ PVP consists of a sperm medium containing 10% oyunoy in the reserved is intended for use as an aid in the immobilization and isolation of individual sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
Substantial Equivalence:
Sydney IVE™ PVP is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Discussion of Tests and Test Results:
Sydney IVF™ PVP was subjected to testing to assure biocompatibility and satisfactory operating performance. Sydney IVF™ PVP passed the requirements of all tests.
Conclusions Drawn from Tests:
This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2004
Ms. Brenda Davis Regulatory Affairs/Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460-6500
Re: K031304
Trade/Device Name: Sydney IVF"" PVP Regulation Number: 21 CFR §884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL Dated: December 23, 2003 Received: December 24, 2003
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 (PMA), it may be subject to 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.
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.
2
.
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K 031304
Device Name: Sydney IVF™ PVP
Indications For Use:
Sydney IVF™ PVP consists of a sperm medium containing 10% Polyvinylpyrrolidone (PVP) and is intended for use as an aid in the immobilization and isolation of indivudal sperm cells prior to intracytoplasmic sperm injection (ICSI) procedures.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.