(58 days)
ASPTM
Not Found
No
The device description and intended use clearly describe a bicarbonate buffered salt solution for rinsing and washing, with no mention of AI/ML or image processing.
No.
The device is a solution for use during in vitro fertilization procedures, specifically for rinsing contact materials and washing the cervix, which are procedural uses rather than direct therapeutic interventions for a disease or condition.
No
The "Intended Use / Indications for Use" states "Solution for use during In Vitro fertilization procedures" and "Solution for rinsing of contact materials and for washing of the cervix. Not for culture." These uses are procedural or preparatory, not for identifying a disease or condition.
No
The device description clearly states it is a "Bicarbonate buffered salt solution," which is a physical substance, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Solution for use during In Vitro fertilization procedures." In vitro fertilization (IVF) is a process performed outside of the living body, and the solutions used in this process are typically considered IVDs because they are used to handle and manipulate biological materials (sperm, eggs, embryos) in a laboratory setting.
- Device Description: The description of a "Bicarbonate buffered salt solution" used in a laboratory setting further supports its use in an in vitro process.
- Lack of In Vivo Use: There is no indication that this solution is introduced into the body for diagnostic purposes. Its use is described as "rinsing of contact materials and for washing of the cervix," which are preparatory steps for an in vitro procedure.
While the description doesn't explicitly state it's for diagnostic purposes in the traditional sense of identifying a disease, the regulatory definition of an IVD is broader and includes reagents, instruments, and systems intended for use in the examination of specimens, including those used in assisted reproductive technologies like IVF.
The fact that it's used in the context of IVF, which involves handling human gametes and embryos outside the body, strongly points towards it being regulated as an IVD.
N/A
Intended Use / Indications for Use
Solution for use during In Vitro fertilization procedures.
Solution for rinsing of contact materials and for washing of the cervix. Not for culture.
Product codes
85 MQL
Device Description
Bicarbonate buffered salt solution. For use after pre-equilibration at +37℃ and 6% CO2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ASPTM
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
Kozz295 IX. PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson
Vitrolife Sweden AB
Mölndalsvägen 30
SE-412 63 Gothenburg
SWEDEN |
| Date Prepared: | July 11, 2002 |
| Trade Name: | G-RINSETM |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | ASPTM |
| Description of the Device: | Bicarbonate buffered salt solution. For use after
pre-equilibration at +37℃ and 6% CO2. |
| Intended Use: | Solution for use during In Vitro fertilization
procedures |
| Technological Characteristics: | The technological characteristics of G-RINSE™
are essentially similar to those of the predicate
device. The G-RINSE is a modification of the
predicate device and formulation changes were
made to improve the performance of the G-
RINSE device. None of these differences raise
new questions of safety or effectiveness. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
FP 12 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vitrolife Sweden AB % Mr. Gary L. Yingling Kirkpatrick & Lockhart 1800 Massachusetts Avenue, NW WASHINGTON DC 20036-1800 Re: K022295
Trade/Device Name: G-RINSETM Assisted Reproduction Media Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II
Product Code: 85 MQL Dated: July 11, 2002 Received: July 16, 2002
Dear Mr. Yingling:
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. Iisting 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 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:
| 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" (21 CFR Part 807.97). 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 STATEMENT X.
510(k) Number:
KD2255
Device Name:
G-RINSE™ Assisted Reproduction Media
Indications For Use:
Solution for rinsing of contact materials and for washing of the cervix. Not for culture.
Daniel A. Seymore
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
(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 C.F.R § 801.109)
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