(30 days)
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
The provided text describes a 510(k) summary for Cook OB/GYN's Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes. However, it does not include detailed information about specific acceptance criteria or a study that clearly defines and proves the device meets those criteria in a format typically seen for medical device performance studies involving AI or complex algorithm evaluations.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a dedicated study.
Here's an analysis based on the provided text, addressing the requested points where information is available, and indicating when it is not:
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1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided document in the context of quantitative performance metrics for the pipettes' function (e.g., success rate of ICSI, embryo viability, etc.). The 510(k) submission relies on demonstrating substantial equivalence.
The "acceptance criteria" for this type of device, as per the submission, appear to be met by:
- Equivalence in indications for use, design, construction, and materials to predicate devices.
- Satisfactory Mouse Embryo Toxicity testing for the borosilicate glass material.
- Adherence to specified process controls and a Quality Assurance Program.
Acceptance Criterion (Inferred from Substantial Equivalence) Reported Device Performance (Inferred from Submission) Equivalence in indications for use "similar to the ... predicate devices" Equivalence in design "similar to the ... predicate devices" Equivalence in construction "similar to the ... predicate devices" Equivalence in materials "similar to the ... predicate devices" Satisfactory Mouse Embryo Toxicity (MET) testing of material "Results show the material meets the requirements of these tests." Adherence to process controls and Quality Assurance "This device will be manufactured according to specified process controls and a Quality Assurance Program." -
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" in the sense of a dataset for evaluating device performance in human or animal subjects. The "test" mentioned is Mouse Embryo Toxicity testing.
- Sample Size: Not specified for MET testing (e.g., number of embryos, batches tested).
- Data Provenance: Not specified for MET testing.
- Retrospective or Prospective: Not applicable, as it's a materials test, not a clinical study.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The evaluation is for substantial equivalence and material safety (Mouse Embryo Toxicity), not for diagnostic or clinical performance requiring "ground truth" established by human experts in the context of complex image or data interpretation.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication is described.
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5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a micro-tool (pipette), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging system. No human reading or AI assistance is involved in its direct function.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the Mouse Embryo Toxicity testing, the "ground truth" would be the observed viability/health of mouse embryos after exposure to the device material, assessed against established biological safety standards for such materials. For substantial equivalence, the "ground truth" is the established regulatory compliance and performance of the predicate devices.
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8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned as this is a physical device.
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9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm.
Summary of the Regulatory Strategy:
The manufacturer, Cook OB/GYN, pursued a 510(k) pathway by demonstrating substantial equivalence of their Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes to legally marketed predicate devices. This approach meant they did not need to conduct in-depth clinical performance studies as would be required for novel devices or AI solutions. Instead, they focused on showing that their devices are "similar with respect to indications for use, materials and physical construction" to existing devices and that the materials used are biologically safe (via Mouse Embryo Toxicity testing). The FDA agreed with this assessment, granting 510(k) clearance.
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Cook Ob/Gyn 1100 W. Morgan Street Spencer, IN 47460 USA Phone: 812-829-6500 Fax: 812-829-1801 www.cookgroup.com
COOK
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted By:
Brenda Davis Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-6500 bdavis(@cookuro.com December 16, 2003
Device:
Trade Name:
Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes
| Proposed Classification Name: | Class II Assisted Reproduction Microtools |
|---|---|
| 85MQH | |
| CFR Reference: | 884.6130 |
Predicate Devices:
Cook OB/GYN understands due to the recent reclassification there are no predicate devices. We have used other devices as well as Cook Australia devices as our predicate to illustrate safety and effectiveness.
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes, Holding Pipettes, and Assisted Hatching/Zona Drilling Pipettes are substantially equivalent to other pipettes in terms of indications for use, design, construction and materials equivalence.
Specifically, these devices are similar to the Intracytoplasmic Micropipet and Holding Micropipet manufactured by Humagen Fertility Diagnostics, Inc., 2345 Hunter's Way (No. 2), Charlottesville, VA 22901-7928, the Laboratory Micropipette Art. No. 33311 and Laboratory Micropipette Art. No. 22218 manufactured by SWEMED LAB International AB, Box 4014 S-421 04 V. Frolunda, Sweden and the (ICSI) pipettes, holding pipettes, denuding pipettes and assisted hatching/zona drilling pipettes manufactured and distributed in Europe by Cook Australia, 12 Electronics Street, Brisbane Industrial Park, Eight Miles Plains, Queensland, 4113, Australia.
Device Description:
The Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes, the Holding Pipettes are used to hold the occyte in position with the application of vacuum during single sperm injection with the micro-injection pipette, the Denuding Pipettes are used to remove cumulus cell layers, and the Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable embryo assisted hatching. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing has been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meet the requirements for section 510(k) substantial equivalence.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2004
Ms. Brenda Davis Regulatory Affairs, Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460 USA
Re: K033903
Trade/Device Name: Intracytoplasmic Sperm Injection (ICSI), Micro-injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted hatching/Zona Drilling Pipettes Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: 85 MQH Dated: December 16, 2003 Received: December 17, 2003
Dear Ms. Davis:
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 (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.
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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 Office of 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 by reference to premarket notification" (21CFR Part 807.97) you may obtain. 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
Page 2
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Indications for Use
510(k) Number (if known): K033903
| Device Name: | Intracytoplasmic Sperm Injection (ICSI) Micro-InjectionPipettes, Holding Pipettes, Denuding Pipettes, AssistedHatching/Zona Drilling Pipettes |
|---|---|
| Indications For Use: | The Intracytoplasmic Sperm Injection (ICSI) Micro-InjectionPipettes are used for the intracytoplasmic single sperminjection of oocytes. The Holding Pipettes are used to holdthe oocyte in position with the application of vacuum. TheDenuding Pipettes are used to remove the cumulus celllayers. The Assisted Hatching/Zona Drilling Pipettes areused to make a hole in the zona pellucida to enableblastomere removal or embryo assisted hatching. |
Prescription Use (Part 21 CFR 801 Subpart D)
ANDYOR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Lynn
(Division Sign-Off) Division Reproductive, Abdominal, and Radiological Device 310(k) Number
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§ 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.