(182 days)
The SunIVF Universal™ Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional invitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation.
The SunIVF Micromanipulation™ Dish is intended to be used to hold human sperm, oocytes and embryos during their manipulation in in vitro procedures of assisted human reproduction, including fertilization by intracytoplasmic sperm injection, assisted hatching, and biopsy.
The SunIVF ICSI™ Dish is intended to be used to hold human oocytes and sperm during the procedure of fertilization by intracytoplasmic sperm injection.
The SunIVF Freezing Dish 1 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.
The SunIVF Freezing Dish 2 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.
The SunIVF Vitrification Dish is intended to be used to hold human oocytes and embryos during the procedures of vitrification.
The SunIVF Rotational Dish is intended to be used to hold human oocytes and embryos during handling and culture.
The SunIVF General Flat Dish – 35 X 10 mm is intended to be used for washing and handling of human oocytes and embryos.
The SunIVF General Flat Dish – 60 X 15 mm is intended to be used for washing and handling of human oocytes and embryos.
The SunIVF General Flat Dish – 90 X 17 mm is intended to be used for washing and handling of human oocytes and embryos.
Not Found
This FDA 510(k) clearance letter for the SunIVF line of assisted reproduction labware (K080395) does not contain the detailed information requested regarding acceptance criteria and a study to prove device performance.
The document is a clearance letter, which states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It does not include:
- A table of acceptance criteria and reported device performance: This type of information would typically be found in the manufacturer's 510(k) submission, not in the FDA's clearance letter.
- Sample size used for the test set and data provenance: Again, this data is part of the submission, not the clearance letter.
- Number of experts and their qualifications for ground truth: This information is not provided.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study results: This type of study is more common for diagnostic imaging AI devices, not for labware. It is not mentioned here.
- Standalone (algorithm only) performance: Not applicable as this is labware, not an algorithm.
- Type of ground truth used: Not applicable as this is labware, not a diagnostic device relying on ground truth.
- Sample size for the training set: Not applicable as this is labware, not an AI/ML algorithm.
- How ground truth for the training set was established: Not applicable.
Explanation Based on Document Content:
The document primarily focuses on:
- Device Identification: Listing the various SunIVF dishes (Universal, Micromanipulation, ICSI, Freezing 1 & 2, Vitrification, Rotational, General Flat dishes) and their product code (MQL, Class II).
- Intended Use: For each dish, it describes its purpose in assisted human reproduction procedures (e.g., holding sperm, oocytes, and embryos during manipulation, culture, IVF, ICSI, cryopreservation).
- Substantial Equivalence: The core of the 510(k) clearance, indicating that the FDA found the device to be as safe and effective as a predicate device already on the market. This often means the new device shares similar technological characteristics and intended uses with existing devices, and as such, does not require new clinical studies to prove performance in the same way a novel device might.
- Regulatory Compliance: Advising the manufacturer of their ongoing responsibilities under the Act (e.g., registration, listing, good manufacturing practices).
Conclusion:
To obtain the detailed information requested about acceptance criteria and performance studies, one would need to access the full 510(k) submission (K080395) made by GenX International, Inc. to the FDA, which is a much more comprehensive document than this clearance letter. The clearance letter itself merely confirms that the FDA concluded the device is substantially equivalent based on the information provided in that submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2008
Mr. Michael D. Cecchi President International. Inc. 393 Soundview Road GUILFORD CT 06443
Re: K080395
Trade/Devices Name: See enclosed list Regulation Number: 21 CFR 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Dated: July 19, 2008 Received: July 25, 2008
Dear Mr. Cecchi:
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 such 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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdfb/industry/support/index.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
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Trade Names of Devices Cleared in International, Inc. Submission K080395
All of the devices below are assisted reproductive labware devices (884.6160, product code MQL, Class II)
and the same of the same of the same of the same of the season of the season
:
- SunIVF Universal Dish .
- SunIVF Micromanipulation Dish .
- . SunIVF ICSI Dish
- SunIVF Freezing Dish 1 .
- . SunIVF Freezing Dish 2
- SunIVF Vitrification Dish .
- SunIVF Rotational Dish .
- SunIVF General Flat Dish 35 X 10 mm .
- SunIVF General Flat Dish 60 X 15 mm .
- SunIVF General Flat Dish 90 X 17 mm .
.
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510 (k) Number (if known): K080395
Device Names: SunIVF Universal™ Dish
Indication for Use:
The SunIVF Universal™ Dish is intended to be used to hold human sperm, oocytes, and embryos during their manipulation and culture in in-vitro procedures of assisted human reproduction, including washing, handling, conventional invitro fertilization, fertilization by intracytoplasmic sperm injection, assisted hatching, biopsy, and cryopreservation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| Over-the Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K080395 |
|---|---|
| --------------- | --------- |
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INDICATIONS FOR USE
510 (k) Number (if known): K080395
Device Names: SunIVF Micromanipulation™ Dish
Indication for Use:
:
The SunIVF Micromanipulation™ Dish is intended to be used to hold human THE Gall VF Mioromanipuliation vitro procedures of assisted human reproduction, oooyted and omaryou untryou wire sperm injection, assisted hatching, and biopsy.
(Please Do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| or | Over-the Counter Use |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K080395 |
|---|---|
| --------------- | --------- |
B.1
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510 (k) Number (if known): K080395
Device Names: SunIVF ICSI™ Dish
Indication for Use:
The SunIVF ICSI™ Dish is intended to be used to hold human oocytes and sperm during the procedure of fertilization by intracytoplasmic sperm injection.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X or Over-the Counter Use __
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INDICATIONS FOR USE
510 (k) Number (if known): K080395
Device Names: SunIVF Freezing Dish 1
Indication for Use:
The SunIVF Freezing Dish 1 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✗ or Over-the Counter Use
liven
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K080395
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INDICATIONS FOR USE
510 (k) Number (if known): K080395
Device Names: SunIVF Freezing Dish 2
Indication for Use:
The Sun!VF Freezing Dish 2 is intended to be used to hold human oocytes and embryos during the procedures of cryopreservation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
Over-the Counter Use
Jubut Leenen
or
(Division Sign-Off) Division of Reproductive, Abdominal Radiological Devices 510(k) Number
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510 (k) Number (if known): K080395
Device Names: SunIVF Vitrification Dish
Indication for Use:
The SunIVF Vitrification Dish is intended to be used to hold human oocytes and embryos during the procedures of vitrification.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X or
Over-the Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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INDICATIONS FOR USE
510 (k) Number (if known): K080395
Device Names: SunIVF Rotational Dish
Indication for Use:
The SunIVF Rotational Dish is intended to be used to hold human oocytes and embryos during handling and culture.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use or
Over-the Counter Use __
Huld Reiner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
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510 (k) Number (if known): K080395
Device Names: SunlVF General Flat Dish – 35 X 10 mm
Indication for Use:
The SunIVF General Flat Dish – 35 X 10 mm is intended to be used for washing and handling of human oocytes and embryos.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or
Over-the Counter Use _
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
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510 (k) Number (if known): K080395
SunIVF General Flat Dish – 60 X 15 mm Device Names:
Indication for Use:
The SunIVF General Flat Dish – 60 X 15 mm is intended to be used for washing and handling of human oocytes and embryos.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use_
or
Over-the Counter Use _________________________________________________________________________________________________________________________________________________________
Julia Lemm
(Division Sign-Off) Division of Reproductive, Abdominal an Radiological Devices 510(k) Number _
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510 (k) Number (if known): K080395
SunIVF General Flat Dish – 90 X 17 mm Device Names:
Indication for Use:
The SunIVF General Flat Dish – 90 X 17 mm is intended to be used for washing and handling of human oocytes and embryos.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use A
ог
Over-the Counter Use
Helb Remm
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.