(458 days)
The Kitazato OPU Needles consisting of:
- Kitazato OPU Needle with Connection Tube, model number Type 2
- . Kitazato OPU Reduced Needle, model number Type 3
are intended to obtain oocytes from ovarian follicles.
The Kitazato OPU Needles are intended to puncture into the vaginal wall and obtain oocytes from ovarian follicles. The OPU Needle with Connection Tube, model number Type 2, product consists of Aspiration Needle with Connection Tube and Silicone Stopper Connector. The OPU Reduced Needle, model number Type 3, product consists of Reduced Aspiration Needle with Connection Tube and Silicone Stopper Connector.
Here's a breakdown of the acceptance criteria and study information for the Kitazato OPU Needle based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Tensile Testing: Withstand 22N for needle tube O.D. <0.55 mm | Passed (supports claims of substantial equivalence) |
| Bending Elasticity Testing: Return to normal position after bending 8° from straight for needle tube O.D. ≤1.0 mm | Passed (supports claims of substantial equivalence) |
| Folding Strength Testing: No fracture of needle tube detected when O.D. ≤1.0 mm and length ≥12mm is folded to 90° | Passed (supports claims of substantial equivalence) |
| Dimensional Testing: Passes outer diameter and length according to specifications | Passed (supports claims of substantial equivalence) |
| Endotoxin Testing: Endotoxin values conform to ≤20 EU/device | Passed (supports claims of substantial equivalence) |
| Sterility Testing: No microbial growth | Passed (supports claims of substantial equivalence) |
| Mouse Embryo Assay: ≥80% expanded to blastocyst stage within 96 hours | ≥80% expanded to blastocyst stage within 96 hours (specifically reported, implying passing) |
| Biocompatibility: Complies with applicable voluntary standards | Passed (supports claims of substantial equivalence) |
| Sterilization: Complies with applicable voluntary standards | Passed (supports claims of substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of needles for tensile testing, number of samples for endotoxin testing). It broadly states that "The Kitazato OPU Needles were tested."
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for demonstrating compliance with specifications.
- Data Provenance: Not explicitly stated, but the submission is from KITAZATO Medical Co., Ltd. in Tokyo, Japan. It is reasonable to infer the testing was conducted in Japan or at a facility accredited by the manufacturer. The studies are retrospective as they were conducted to demonstrate the device meets criteria before market approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable for the non-clinical performance studies described in this 510(k) summary. These tests are laboratory-based and measure physical, chemical, and biological properties, not human interpretation of medical data. Therefore, there is no "ground truth" established by human experts in the clinical sense for these specific tests.
4. Adjudication Method for the Test Set
This is not applicable because the tests are laboratory-based and yield objective measurements or observations (e.g., pass/fail, numerical values, presence/absence of microbial growth). There is no "adjudication" required in the context of expert review or consensus for these non-clinical tests.
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
No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (OPU Needle), not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical instrument and does not involve any algorithms or AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests are the pre-defined acceptance criteria and specifications themselves. For example:
- For Mechanical Tensile Testing, the ground truth is "withstanding 22N."
- For Endotoxin Testing, the ground truth is "≤20 EU/device."
- For the Mouse Embryo Assay, the ground truth is "≥80% expanded to blastocyst stage within 96 hours."
- For Biocompatibility and Sterilization, the ground truth is compliance with "applicable voluntary standards."
These are objective, measurable performance standards.
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device, there is no "training set" like there would be for an AI algorithm. The manufacturing process is controlled, and products are testedbatch-wise or according to a sampling plan defined by a quality management system.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
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K112462
page 1 of 3
510(k) Summary
For
NOV 2 6 2012
Kitazato OPU Needle
1. Submission Sponsor
KITAZATO Medical Co., Ltd. 2-15-12 Hongo, Bunkyou-ku Tokyo 113-0033 JAPAN Phone: +(81) 3-5800-6055 Fax: +(81) 3-5800-6056 Contact: Mari Yazaki, Quality Assurance Manager
2. Submission Correspondent
Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: (508) 838.9139 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Richard Vincins, Vice President, QA Email: richard@emergogroup.com
3. Date Prepared
21 November 2012
·
4. Device Name
| Trade/Proprietary Name: | Kitazato OPU Needle with Connection Tube, model numberType 2Kitazato OPU Reduced Needle, model number Type 3 |
|---|---|
| Common/Usual Name: | OPU Needle |
| Classification Name: | Assisted Reproduction Needles |
| Classification Regulation: | 884.6100 |
| Classification Panel: | Obstetrics/Gynecology |
| Product Code: | MQE |
| Device Class: | II |
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K112462
Page 20 of 3
5. Predicate Devices
Vitrolife Sweden AB -- Follicle Aspiration Set, Reduced Single Lumen (K082727) Swemed Lab International AB - Swemed Follicle Aspiration Set, Double Lumen, Single Lumen, and Luer Needle (K991273)
Device Description 6.
The Kitazato OPU Needles are intended to puncture into the vaginal wall and obtain oocytes from ovarian follicles. The OPU Needle with Connection Tube, model number Type 2, product consists of Aspiration Needle with Connection Tube and Silicone Stopper Connector. The OPU Reduced Needle, model number Type 3, product consists of Reduced Aspiration Needle with Connection Tube and Silicone Stopper Connector.
The OPU Needle with Connection Tube, model number Type 2, includes the following models:
| Model | Color ofHub | NeedleO.D. (mm) | NeedleGauge | Needle Length (mm) | Connection Tube Length (mm) |
|---|---|---|---|---|---|
| Type2 -v1 | White | 1.65 | 16 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v2 | Lightbrown | 1.49 | 17 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v3 | Pink | 1.25 | 18 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v4 | Ivory | 1.06 | 19 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v5 | Yellow | 0.90 | 20 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v6 | Green | 0.80 | 21 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v7 | Black | 0.70 | 22 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v8 | Lightblue | 0.63 | 23 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v9 | Purple | 0.55 | 24 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
The OPU Reduced Needle, mode number Type 3, includes the following models:
| Model | NeedleGauge | NeedleQ.D.(mm) | NarrowTipGauge | NarrowTip O.D.(mm) | Needle Length(mm) | Color ofHub | Length ofReducedNeedle(mm) | ConnectionTubeLength(mm) |
|---|---|---|---|---|---|---|---|---|
| Type3 -v1 | 18 | 1.25 | 21 | 0.80 | 200, 225, 250,275, 300, 325, 350 | Green | 40-60 | 800 |
| Type3 -v2 | 18 | 1.25 | 22 | 0.70 | 200, 225, 250,275, 300, 325, 350 | Black | 40-60 | 800 |
| Type3 -v3 | 18 | 1.20 | 23 | 0.63 | 200, 225, 250,275, 300, 325, 350 | Light blue | 40-60 | 800 |
7. Intended Use
The Kitazato OPU Needles consisting of:
- Kitazato OPU Needle with Connection Tube, model number Type 2
- . Kitazato OPU Reduced Needle, model number Type 3
are intended to obtain oocytes from ovarian follicles.
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K112462
page 3 of 3
8. Substantial Equivalence Discussion
The indication for use and technology of the OPU Needle are substantially equivalent to the identified predicate devices.
9. Non-Clinical Testing
The needle mechanical tensile testing and mouse embryo testing results supports that all the specifications have met the acceptance criteria for the device. The Kitazato OPU Needles passed all testing and supports the claims of substantial equivalence.
- . Mechanical Tensile Testing: Tensile strength to withstand 22N for needle tube O.D. <0.55 mm
- . Bending Elasticity Testing: Return normal position after bending 8° from straight for needle tube O.D. ≤1.0 mm
- Folding Strength Testing: No fracture of needle tube is detected when needle tube . of O.D. ≤1.0 mm and length ≥12mm is folded to 90°
- Dimensional Testing: Passes outer diameter and length according to specifications .
- Endotoxin Testing: Endotoxin values conform to the value ≤20 EU/device �
- Sterility Testing: No microbial growth from sterility testing .
- t Mouse Embryo Assay: ≥80% expanded to blastocyst stage within 96 hours
The Kitazato OPU Needles were tested and complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
10. Conclusion
:
The Kitazato OPU Needles are substantially equivalent to its proposed predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 26, 2012
KITAZATO Medical Co., Ltd. % Richard Vincins, CQA, CBA, RAC (US,EU) Vice President, Quality Assurance Emergo Group 611 West 5th Street, Third Floor AUSTIN TX 78701
Re: K112462
Trade/Device Name: Kitazato OPU Needle Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted reproduction needles Regulatory Class: II Product Code: MQE Dated: November 6, 2012 Received: November 15, 2012
Dear Mr. Vincins:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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Page 2 - Richard Vincins, CQA, CBA, RAC(US,EU)
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert R. Lerner
-Acting Director for-Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use Statement
510(k) Number (if known): K112462
Device Name: Kitazato OPU Needle
Indications for Use:
The Kitazato OPU Needles consisting of:
- Kitazato OPU Needle with Connection Tube, model number Type 2 .
| Model | Color of Hub | Needle O.D. (mm) | Needle Gauge | Needle Length (mm) | Connection Tube Length (mm) |
|---|---|---|---|---|---|
| Type2 -v1 | White | 1.65 | 16 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v2 | Light brown | 1.49 | 17 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v3 | Pink | 1.25 | 18 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v4 | Ivory | 1.06 | 19 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v5 | Yellow | 0.90 | 20 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v6 | Green | 0.80 | 21 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v7 | Black | 0.70 | 22 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v8 | Light blue | 0.63 | 23 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
| Type2 -v9 | Purple | 0.55 | 24 | 200, 225, 250, 275, 300, 325, 350 | 200, 300, 400, 600, 800, 1000 |
- Kitazato OPU Reduced Needle, model number Type 3 .
| Model | NeedleGauge | NeedleO.D.(mm) | NarrowTipGauge | NarrowTip O.D.(mm) | Needle Length(mm) | Color ofHub | Length ofReducedNeedle(mm) | ConnectionTube Length(mm) |
|---|---|---|---|---|---|---|---|---|
| Type3 -v1 | 18 | 1.25 | 21 | 0.80 | 200, 225, 250, 275,300, 325, 350 | Green | 40-60 | 800 |
| Type3 -v2 | 18 | 1.25 | 22 | 0.70 | 200, 225, 250, 275,300, 325, 350 | Black | 40-60 | 800 |
| Type3 -v3 | 18 | 1.20 | 23 | 0.63 | 200, 225, 250, 275,300, 325, 350 | Light blue | 40-60 | 800 |
are intended to obtain oocytes from ovarian follicles.
Prescription Use ____________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _____________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner
Acting Director for Benjamin R. Fisher, Ph.D.
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K112462 510/k) Numhar
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).