(124 days)
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Not Found
No
The summary describes a physical micropipette and tip for transferring blastomeres, with no mention of software, image processing, or AI/ML terms.
No
The device's intended use is for the transfer of a removed blastomere, not for diagnosing, treating, or preventing disease or affecting the structure/function of the body, which are characteristics of a therapeutic device. It specifically states "NOT intended for blastomere biopsy from an embryo", further indicating it's not performing a direct medical intervention.
No
The device's intended use is for the physical transfer of a blastomere, not for diagnosing any condition.
No
The device description explicitly states "Stripper PGD® Micropipette and associated tip," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the transfer of a removed blastomere. It explicitly states it is not intended for blastomere biopsy. IVDs are typically used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is handling a sample that has already been obtained.
- Device Description: The description is of a micropipette and tip, which are tools for manipulating small samples, not for performing diagnostic tests on those samples.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze the blastomere or provide any diagnostic information about it.
Therefore, based on the provided text, the device's function is a laboratory manipulation task, not a diagnostic test performed on a specimen from the human body.
N/A
Intended Use / Indications for Use
The Stripper PGD® indications for use are:
- The transfer of the removed blastomere from a holding vessel to a transport vessel.
- This device is NOT intended for blastomere biopsy from an embryo.
Product codes
85 MQH
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
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo is circular and contains the department's seal. The seal features an abstract design of three wavy lines, possibly representing people, and the text "Department of Health & Human Services USA" arranged around the circle.
Public Health Service
SEP 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan J. Bush Regulatory Affairs MidAtlantic Diagnostics, Inc. 438 N. Elmwood Road * Marlton NJ 08053
Re: K041435
Trade/Device Name: Stripper PGD® Micropipette and associated tip Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II
Product Code: 85 MQH Dated: August 23, 2004 Received: August 26, 2004
Dear Ms. Bush:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
^
This letter will allow you to begin marketing your device as described in your Section 510(k) I us letter will and in your of substantial equivalence of your device to a legally prematicated predicated." The aclassification 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 11 you deen bepoent 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 Other over to premarket notification" (21CFR Part 807.97) you may obtain. Other general by reference to promation 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
Page 2
2
Indications for Use
510(k) Number (if known): __ K041435
Device Name: The Stripper PGD®
Indications for Use:
- The transfer of the removed blastomere from a holding vessel to a ﺳ transport vessel.
- This device is NOT intended for blastomere biopsy from an embryo. -
Prescription Usc (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Legmann
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 84143. 510(k) Number _
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