(30 days)
The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of Blastomeres for pre-implantation genetic diagnosis.
The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are used for the aspiration of The Tre Implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile. These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
The provided text is a 510(k) Summary of Safety and Effectiveness for the Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes), along with the FDA's clearance letter. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed studies with specific acceptance criteria, performance metrics, and human reader studies as would be seen for complex AI/ML-driven or diagnostic devices.
Therefore, the information requested in your prompt related to specific performance criteria, statistical study details (sample sizes for test/training sets, ground truth establishment, expert adjudication), and AI-specific elements (MRMC studies, standalone performance with AI) is not present in this document. This is because the device is a simple medical tool (pipettes) and the 510(k) pathway primarily requires demonstrating equivalence, not extensive clinical performance studies in the same vein as more complex devices.
However, I can extract the information that is available:
Acceptance Criteria and Device Performance (Limited Information)
The document states equivalence to predicate devices based on materials, design, and function, rather than specific numerical performance metrics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Safety: Non-toxic and endotoxin-free materials for patient contact. | Mouse Embryo Toxicity Testing: Material meets requirements. |
| Endotoxin Testing: Material free from harmful levels of endotoxins. | Endotoxin Testing: Material meets requirements. |
| Substantial Equivalence: Similar indications for use, design, construction, and materials to predicate devices. | The device is substantially equivalent to Cook Australia devices, specifically those manufactured by Cook Docencialia in Europe. |
Study Details (Limited; focus on material safety)
Given the nature of the device (borosilicate glass pipettes), the "studies" performed were primarily material testing.
- Sample size used for the test set and the data provenance: Not specified for "Mouse Embryo Toxicity testing" and "Endotoxin testing." The provenance would be Cook OB/GYN labs or a contracted testing facility. This would be a prospective test of newly manufactured materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material testing typically follows standardized protocols, and results are interpreted according to pre-defined thresholds, not through expert consensus on a "ground truth" derived from cases.
- Adjudication method for the test set: Not applicable for material testing.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is relevant for diagnostic imaging or AI devices, not for basic medical tools like pipettes.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is not an AI/algorithm-driven device.
- The type of ground truth used: For the material testing, the "ground truth" is adherence to established biological safety standards, as determined by the results of the Mouse Embryo Toxicity and Endotoxin tests against their respective benchmarks.
- The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Device and Regulatory Context:
The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) by Cook OB/GYN are simple borosilicate glass tools intended for aspirating blastomeres for pre-implantation genetic diagnosis. The 510(k) submission focused on demonstrating substantial equivalence to existing pipettes, specifically noting Cook Australia devices as predicates. The key evidence provided for safety and effectiveness related to the materials used: Mouse Embryo Toxicity testing and Endotoxin testing were performed on the borosilicate glass, and the results indicated the material met the required standards. No clinical performance data, AI algorithm performance, or human reader studies were presented or required for this type of device and regulatory pathway.
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JAN 1 6 2004
OOK®
Cook Ob/Gyn 1100 W. Morgan Street Spencer, IN 47460 USA Phone: 812-829-6500 Fax: 812-829-1801 www.cookgroup.com
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 Decemember 15, 2003
Device:
Trade Name:
Pre-Implantation Genetic Diagnosis Pipettes (Biopsy 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 Cook Australia devices as our predicate to illustrate safety and effectiveness.
The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are substantially equivalent to other pipettes in terms of indications for use, design, construction and material equivalence.
Specifically, these devices are similar to the Pipettes manufactured and distributed in Europe by Cook Docencialia, 12 Electronics Street, Brisbane Industrial Park, Eight Miles Plains, Queensland, 4113, Australia.
Device Description:
The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are used for the aspiration of The Tre Implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile.
These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
Substantial Equivalence:
Substantial inquiratened 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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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: K033904
Trade/Device Name: Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) Regulation Number: 21 CFR 884.6130 Regulation Name: Assisted reproduction microtools Regulatory Class: II Product Code: 85 MQH Dated: December 15, 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) I his letter will and in you to organ finding of substantial equivalence of your device to a legally prematication. "The 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 If you desire specific at ne 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 Addition of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or of or oremarket 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 miorination on Journational 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. Brygden
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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Indications for Use
510(k) Number (if known): K033904
- Pre-Implantation Genetic Diagnosis Pipettes Device Name: (Biopsy Pipettes)
- The Pre-Implantation Genetic Diagnosis Pipettes are used Indications For Use: for the aspiration of Blastomeres for pre-implantation genetic diagnosis.
Prescription Use × (Part 21 CFR 801 Subpart D) ANBIOR
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 A. Layman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic
510(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.