(86 days)
Not Listed
Not Found
No
The device description and intended use are focused on a chemical substance (PVP) used as a medium, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is used to immobilize sperm during ICSI procedures, which is a supportive role in an ART procedure rather than directly treating a disease or condition.
No
This device, PVP, is used for sperm immobilization during ICSI procedures, which is a treatment/manipulative function, not a diagnostic one.
No
The device description clearly states that the device is composed of polyvinylpyrrolidone dissolved in water and lyophilized, indicating it is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "assisted reproductive technology procedures involving the manipulation of gametes" and specifically for "immobilization of sperm during intracytoplasmic sperm injection (ICSI) procedures." These are procedures performed in vitro (outside the body) on biological samples (gametes/sperm).
- Device Description: The description confirms it's a substance (PVP dissolved in water) used as a "medium" for manipulating these biological samples.
- Predicate Device: The reference to a "Notice of Final Rule" and a Docket number related to a rule change strongly suggests it falls under regulatory oversight for medical devices, and given the intended use, it's highly likely to be regulated as an IVD.
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 device isn't directly diagnosing a disease, it's a critical component used in a procedure (ICSI) that addresses infertility, which is considered a medical condition. The manipulation of gametes in vitro for this purpose falls squarely within the scope of IVD regulation.
N/A
Intended Use / Indications for Use
PVP is intended for use as an aid in the immobilization and isolation of sperm prior to intracytoplasmic sperm injection (ICSI) procedures.
PVP (polyvinylpyrrolidone) is intended for use in assisted reproductive technology procedures involving the manipulation of gametes. Specifically, PVP is intended for use as a medium for the immobilization of sperm during intracytoplasmic sperm injection (ICSI) procedures.
Product codes
85 MQL
Device Description
PVP consists of polyvinylpyrrolidone that has been dissolved in ultra-pure water and Ivophilized.
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
PVP 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 standard media used for the immobilization and isolation of human sperm cells for use in ICSI procedures.
Key Metrics
Not Found
Predicate Device(s)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Irvine Scientific
Image /page/0/Picture/2 description: The image shows the date JUL 14 1999 and the number K991343 at the top. Below this text is a black and white logo. The logo is a stylized design, possibly representing initials or a company symbol. The letters 'TM' are located at the bottom right of the logo.
1999
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: April 16, 1999
Device Identification:
| Trade Name: | PVP-Polyvinylpyrrolidone |
|---|---|
| Common Name: | Sperm Immobilization Medium |
| Classification Name: | Reproductive Media (21 CFR, 886.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
PVP consists of polyvinylpyrrolidone that has been dissolved in ultra-pure water and Ivophilized.
Intended Use:
PVP is intended for use as an aid in the immobilization and isolation of sperm prior to intracytoplasmic sperm injection (ICSI) procedures.
PVP (Polyvinylpyrrolidone)
Page 23 of 27
1
Technological Characteristics:
Intracytoplasmic sperm injection (ICSI) procedures are typically performed in those instances where infertility is either caused by severe male factor (i.e. poor quality or insufficient number of sperm) or is of unknown cause, and where traditional in vitro fertilization procedures have not resulted in pregnancy. In ICSI, viable sperm cells are concentrated and purified, and then isolated in a culture dish, where a single cell is aspirated into a pipette or syringe, and injected into an ovum. PVP is used to assist in the isolation and immobilization of sperm, prior to ICSI procedures.
Performance Data:
PVP 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 standard media used for the immobilization and isolation of human sperm cells for use in ICSI procedures.
Additional Information:
Endotoxin, hamster sperm penetration assay performance and sterility tests will be performed as a condition of release for this product. Results of all release assays performed will be reported on a lot-specific certificate of analysis, and will be indicated on the labeling.
Conclusion:
The conclusion from a review of the historical information contained in professional literature shows that PVP is suitable for its intended use, and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 14 1999
Ms. Roberta L. Johnson Manager, Regulatory Affairs Irvine Scientific, Inc. 2511 Daimler Street Santa Ana, CA 92705-5588 Re: K991343 Polyviny Dated: April 16, 1999 Received: April 19, 1999 Requiatory 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, 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 Requlation (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 requirin regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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
3
INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number: KGQ 1343
Device Name:_PVP (Polyvinylpyrrolidone)
Indications for Use:
PVP (polyvinylpyrrolidone) is intended for use in assisted reproductive technology procedures involving the manipulation of gametes. Specifically, PVP is intended for use as a medium for the immobilization of sperm during intracytoplasmic sperm injection (ICSI) procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ra-C. Pally
(Division Sign-On)
Division of Re- Muctive, Abdominal, ENT, and Radiologi . . 510(k) Number
Prescription Use
(Per 21 CFR 801.109)