(458 days)
Not Found
No
The document describes a mechanical device (needles) for oocyte retrieval and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an OPU needle intended to obtain oocytes from ovarian follicles, which is a diagnostic or collection procedure, not a treatment for a disease or condition.
No
The device is intended to obtain oocytes, which is a therapeutic rather than diagnostic procedure.
No
The device description clearly states it is a physical needle with a connection tube and silicone stopper, intended for puncturing and obtaining oocytes. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. This examination is performed outside of the body (in vitro).
- Device Function: The Kitazato OPU Needles are used to obtain oocytes directly from the ovarian follicles within the body. They are a surgical/procedural tool for retrieval, not for analyzing a specimen in vitro.
- Intended Use: The intended use is to "obtain oocytes from ovarian follicles," which is a collection process, not a diagnostic test performed on a collected sample.
- Device Description: The description focuses on the physical act of puncturing and obtaining oocytes, not on any analytical or diagnostic function.
- Lack of Diagnostic Information: The documentation does not mention any output or result that provides diagnostic information about the patient's health or condition. The performance studies focus on the physical properties of the needle and its impact on embryo development (which is related to the use of the collected oocytes, not a diagnostic test on the oocytes themselves).
In summary, the Kitazato OPU Needles are a medical device used for a collection procedure, not for performing a diagnostic test on a sample outside the body.
N/A
# Intended Use / Indications for 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.
# Product codes (comma separated list FDA assigned to the subject device)
MQE
# Device Description
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 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 |
The OPU Reduced Needle, mode number Type 3, includes the following models:
| Model | Needle Gauge | Needle Q.D. (mm) | Narrow Tip Gauge | Narrow Tip O.D. (mm) | Needle Length (mm) | Color of Hub | Length of Reduced Needle (mm) | Connection Tube 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 |
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
ovarian follicles, vaginal wall
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
Not Found
# Description of the training set, sample size, data source, and annotation protocol
Not Found
# 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)
Non-Clinical Testing:
- Mechanical Tensile Testing: Tensile strength to withstand 22N for needle tube O.D. =12mm is folded to 90°
- Dimensional Testing: Passes outer diameter and length according to specifications
- Endotoxin Testing: Endotoxin values conform to the value =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.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K082727](https://510k.innolitics.com/search/K082727), [K991273](https://510k.innolitics.com/search/K991273)
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 number
Type 2
Kitazato 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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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 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 |
The OPU Reduced Needle, mode number Type 3, includes the following models:
| Model | Needle
Gauge | Needle
Q.D.
(mm) | Narrow
Tip
Gauge | Narrow
Tip O.D.
(mm) | Needle Length
(mm) | Color of
Hub | Length of
Reduced
Needle
(mm) | Connection
Tube
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 |
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.