K Number
K080395
Device Name
SUNIVF DISHES
Manufacturer
Date Cleared
2008-08-13

(182 days)

Product Code
Regulation Number
884.6160
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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. 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.
Device Description
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More Information

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No
The device description and intended use clearly describe laboratory dishes for holding biological samples. There is no mention of any computational or analytical capabilities, let alone AI/ML.

Yes
The devices are intended to hold human sperm, oocytes, and embryos during in-vitro procedures of assisted human reproduction, which are medical procedures designed to treat or prevent disease (infertility) or affect the structure or function of the body, thus qualifying them as therapeutic devices.

No

The text describes various dishes designed to hold biological materials (sperm, oocytes, embryos) during assisted human reproduction procedures like washing, handling, fertilization, and cryopreservation. These are containment and manipulation tools, not devices that provide diagnostic information about a patient's condition or disease state.

No

The intended use describes physical dishes used to hold biological materials, indicating a hardware device, not software.

Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).

Here's why:

  • IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The intended uses described for these dishes are for holding and manipulating human reproductive cells (sperm, oocytes, embryos) during assisted reproductive procedures. They are containers and tools for handling, not for performing diagnostic tests on the specimens themselves.
  • The intended uses focus on the physical manipulation and culture of the cells, not on analyzing them to diagnose a condition, monitor a treatment, or determine compatibility.

These devices are likely considered medical devices used in assisted reproductive technology (ART) procedures, but they do not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications 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.

The SunIVF Micromanipulation™ Dish is intended to be used to hold human oooyted and omaryou untryou wire 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.

Product codes

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)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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.

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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.

1

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
Other240-276-0100

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

2

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 .

.

3

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 UseX
Over-the Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

510(k) NumberK080395
------------------------

4

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 UseX
orOver-the Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices

510(k) NumberK080395
------------------------

B.1

5

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 __

6

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

7

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

8

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

9

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 __

10

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 _

11

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 _

12

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