(270 days)
Not Found
No
The device description and performance studies focus on the physical properties, sterility, and biocompatibility of a needle used for oocyte collection. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
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 therapeutic treatment.
No
The device is a medical instrument used for collecting oocytes, which is a therapeutic or procedural function, not a diagnostic one. It does not provide information to diagnose a condition.
No
The device description clearly states that the Kitazato OPU Needles are physical, single-use sterile devices made of stainless steel, ABS, PVC, and silicone. The performance studies also focus on physical properties and biological interactions of these materials.
Based on the provided information, the Kitazato OPU Needles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "obtain oocytes from ovarian follicles." This is a procedure performed on the patient's body to collect biological material.
- Device Description: The device is a needle used for "ultrasound-guided transvaginal collection of oocytes." This describes a surgical or procedural tool used for collection, not for testing or analyzing a sample in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device being used to analyze or test the collected oocytes or any other biological sample. The performance studies focus on the physical properties of the needle, sterility, biocompatibility, and its ability to collect oocytes, not on any diagnostic accuracy or analytical performance.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Kitazato OPU Needles are a tool for collecting the specimen, not for performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Kitazato OPU Needles consisting of:
- · Kitazato OPU Needle with Connection Tube (model number Type2)
- · Kitazato OPU Reduced Needle (model number Type3)
- · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
are intended to obtain oocytes from ovarian follicles.
Product codes (comma separated list FDA assigned to the subject device)
MOE
Device Description
The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.
The Type2 OPU Needles consist of straight aspiration needles (no tapering) with the following characteristics:
| Model | Color of Hub | Needle O.D. (mm) | Needle Gauge | Needle Length (mm) | Needle ID (mm) | Wall Thickness (mm) | Needle Bevel Angle | Connection Tube Length (mm) | Connection Tube O.D. (mm) | Connection Tube ID (mm) | Stopper Size | Tube size Compatible with Stopper |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type2 v1/-v10 | White | 1.65 | 16 | 350 | 1.19 | 0.23 | 14° | 800, 1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type2 v2/v11 | Light brown | 1.49 | 17 | 350 | 1.06 | 0.22 | 14° | 800, 1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type2 v3/v12 | Pink | 1.25 | 18 | 350 | 0.86 | 0.20 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2 v4/v13 | Ivory | 1.06 | 19 | 350 | 0.74 | 0.16 | 14° | 800, 1000 | 2.0 | 1.0 | 2.5 | 1.0 (2.5) |
| Type2 v5/v14 | Yellow | 0.90 | 20 | 350 | 0.64 | 0.13 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2 v6/v15 | Yellow | 0.90 | 20 | 300 | 0.64 | 0.13 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2 v7/v16 | Green | 0.80 | 21 | 300 | 0.54 | 0.13 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2 v8/v17 | Black | 0.70 | 22 | 300 | 0.43 | 0.13 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2 v9/v18 | Light blue | 0.63 | 23 | 300 | 0.39 | 0.12 | 14° | 800, 1000 | 2.0 | 1.0 | 2.5 | 1.0 (2.5) |
The Type3 OPU Needles consist of aspiration needles with a tapered tip over the distal 40 or 100 mm of the tip. The table below shows the features of the Type3 OPU Needles:
| Model | Color of Hub | Needle O.D. (mm) M: main T: Tapered O.D. | Needle Gauge M: main T: Tapered Gauge | Needle Length (mm) TL: Tapered Length | Needle ID (mm) M: main T: Tapered I.D. | Wall Thick ness (mm) | Needle Bevel Angle | Connection Tube Length (mm) | Connection Tube O.D. (mm) | Connection Tube ID (mm) | Stopper Size | Tube size Compatible with Stopper |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type3 -v1 | Green | M 1.25 T 0.80 | M 18 T 21 | 300, 325 350 TL-40 | M-0.86 T-0.54 | 0.195 T-0.13 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3 -v2 | Black | M 1.25 T 0.70 | M 18 T 22 | 300, 325 350 T-40 | M-0.86 T-0.45 | 0.195 T-0.13 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3 -v3 | Light Blue | M 1.25 T 0.63 | M 18 T 23 | 300, 325 T-40 | M-0.86 T-0.43 | 0.195 T-0.10 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3 -v4 | Ivory | M 1.49 T 1.06 | M 17 T 19 | 300, 325 350 T-100 | M-1.20 T-0.78 | 0.145 T-0.14 | 14° | 800, 1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type3 -v5 | Yellow | M 1.49 T 0.90 | M 17 T 20 | 300, 325 350 T-100 | M-1.20 T-0.62 | 0.145 T-0.14 | 14° | 800, 1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type3 -v6 | Green | M 1.25 T 0.80 | M 18 T 21 | 300, 325 T-100 | M-0.86 T-0.54 | 0.195 T-0.13 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3 -v7 | Black | M 1.25 T 0.70 | M 18 T 22 | 300, 325 T-100 | M-0.86 T-0.45 | 0.195 T-0.13 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3 -v8 | Light Blue | M 1.25 T 0.63 | M 18 T 23 | 300, 325 T-100 | M-0.86 T-0.43 | 0.195 T-0.10 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
The Type4 OPU Needles consist of aspiration needles that taper at two locations at the distal tip of the device, with the first taper beginning 70 mm from the tip and the second starting 25 mm from the tip. The table below shows the features of the Type4 OPU Needles.
| Model | Color of Hub | Needle O.D. (mm) M: main T1: 1st Step Tapered T2 : 2nd Step Tapered | Needle Gauge M: main T1: 1st Step Tapered T2: 2nd Step Tapered | Needle Length (mm) M: main T1: 1st Step Tapered T2 : 2nd Step Tapered | Needle ID (mm) M: main T2: 2nd Step Tapered | Wall Thickness (mm) | Needle Bevel Angle | Connection Tube Length (mm) | Connection Tube O.D. (mm) | Connection Tube ID (mm) | Stopper Size | Tube size Compatible with Stopper |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Type4 -v1 | Green | M-1.25 T1-1.06 T2-0.80 | M-18/ T1-19, T2-21 | M-300 T1-70 T2-25 | M-0.98 T2-0.54 | 0.135 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type4 -v2 | Black | M-1.25 T1-0.90 T2-0.70 | M-18/ T1-20 T2-22 | M 300 T1-70 T2-25 | M-0.98 T2-0.43 | 0.135 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type4 -v3 | Light Blue | M-1.25 T1-0.80 T2-0.63 | M-18/ T1-21 T2-23 | M-300 T1-70 T2-25 | M-0.98 T2-0.39 | 0.135 | 14° | 800, 1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound-guided
Anatomical Site
ovarian follicles
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 Performance Data:
- Endotoxin testing per ANSI/AAMI ST72-2011:
§ 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms a ribbon-like shape at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
Kitazato Corporation % Audrey Swearingen Director, Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746
Re: K162881 Trade/Device Name: Kitazato OPU Needles Regulation Number: 21 CFR§ 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MOE Dated: June 2, 2017 Received: June 2, 2017
Dear Audrey Swearingen:
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.
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.
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Joyce M. Whang -S
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
2
Indications for Use
510(k) Number (if known) K162881
Device Name Kitazato OPU Needles
Indications for Use (Describe) The Kitazato OPU Needles consisting of:
- · Kitazato OPU Needle with Connection Tube (model number Type2)
- · Kitazato OPU Reduced Needle (model number Type3)
- · Kitazato OPU Two-Stage Reduced Needle (model number Type4)
are intended to obtain oocytes from ovarian follicles.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Kitazato OPU Needles – K162881
1. Submission Sponsor
Kitazato Corporation 1-1-8 Shibadaimon, Minato-ku Tokyo 105-0012 JAPAN Contact: Ms. Mari Yazaki Title: Quality Assurance Manager Phone: (81) 3-3434-2731 Fax: (81) 3-3434-2732 Email: yazaki@kitazato.co.jp
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 Contact: Audrey Swearingen, RAC Title: Director, Regulatory Affairs
3. Date Prepared
July 7, 2017
4. Device Identification
| Trade or Proprietary Name: | Kitazato OPU Needles |
|---|---|
| Common or Usual Name: | Oocyte aspiration needle |
| Regulation Number: | 884.6100 |
| Regulation Name: | Assisted Reproduction Needles |
| Product Code: | MQE |
| Product Code Name: | Needles, Assisted Reproduction |
| Class of Device: | Class II |
| Panel: | Obstetrics/Gynecology |
5. Legally Marketed Predicate Device(s)
KITAZATO Medical Co., Ltd., K112492, Kitazato OPU Needle with Connection Tube, Type2 and Kitazato OPU Reduced Needle, Type 3.
The predicate device has not been subject to a design-related recall.
Indication for Use Statement 6.
The Kitazato OPU Needles consisting of:
- Kitazato OPU Needle with Connection Tube (model number Type2)
- Kitazato OPU Reduced Needle (model number Type3)
- Kitazato OPU Two-Stage Reduced Needle (model number Type4)
4
are intended to obtain oocytes from ovarian follicles.
7. Device Description
The Kitazato OPU Needles are single-use sterile devices that are used for ultrasound-guided transvaginal collection of oocytes from ovarian follicles.
All of the Kitazato OPU Needle have a similar general design and device materials. All of the Kitazato OPU Needles are composed of a 304 stainless steel needle, acrylonitrile butadiene styrene (ABS) needle hub, PVC connection tube, and a silicone stopper that is used to connect to a collection tube and vacuum pump.
The Type2 OPU Needles consist of straight aspiration needles (no tapering) with the following characteristics:
| Model | Color
of
Hub | Needle
O.D.
(mm) | Needle
Gauge | Needle
Length
(mm) | Needle
ID
(mm) | Wall
Thickness
(mm) | Needle
Bevel
Angle | Connection
Tube
Length
(mm) | Connection
Tube
O.D.
(mm) | Connection
Tube
ID
(mm) | Stopper
Size | Tube
size
Compatible
with
Stopper |
|------------------|--------------------|------------------------|-----------------|--------------------------|----------------------|---------------------------|--------------------------|--------------------------------------|------------------------------------|----------------------------------|-----------------|-----------------------------------------------|
| Type2
v1/-v10 | White | 1.65 | 16 | 350 | 1.19 | 0.23 | 14° | 800,
1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type2
v2/v11 | Light
brown | 1.49 | 17 | 350 | 1.06 | 0.22 | 14° | 800,
1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type2
v3/v12 | Pink | 1.25 | 18 | 350 | 0.86 | 0.20 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2
v4/v13 | Ivory | 1.06 | 19 | 350 | 0.74 | 0.16 | 14° | 800,
1000 | 2.0 | 1.0 | 2.5 | 1.0 (2.5) |
| Type2
v5/v14 | Yellow | 0.90 | 20 | 350 | 0.64 | 0.13 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2
v6/v15 | Yellow | 0.90 | 20 | 300 | 0.64 | 0.13 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2
v7/v16 | Green | 0.80 | 21 | 300 | 0.54 | 0.13 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2
v8/v17 | Black | 0.70 | 22 | 300 | 0.43 | 0.13 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type2
v9/v18 | Light
blue | 0.63 | 23 | 300 | 0.39 | 0.12 | 14° | 800,
1000 | 2.0 | 1.0 | 2.5 | 1.0 (2.5) |
The Type3 OPU Needles consist of aspiration needles with a tapered tip over the distal 40 or 100 mm of the tip. The table below shows the features of the Type3 OPU Needles:
| Model | Color
of
Hub | Needle
O.D.
(mm)
M: main
T:
Tapered
O.D. | Needle
Gauge
M: main
T:
Tapered
Gauge | Needle
Length
(mm)
TL:
Tapered
Length | Needle
ID
(mm)
M: main
T:
Tapered
I.D. | Wall
Thick
ness
(mm) | Needle
Bevel
Angle | Connec
tion
Tube
Length
(mm) | Connec
tion
Tube
O.D.
(mm) | Connec
tion
Tube
ID
(mm) | Stopper
Size | Tube size
Compatible
with
Stopper |
|--------------|--------------------|------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------|-------------------------------|--------------------------|------------------------------------------|----------------------------------------|--------------------------------------|-----------------|--------------------------------------------|
| Type3
-v1 | Green | M 1.25
T 0.80 | M 18
T 21 | 300, 325
350
TL-40 | M-0.86
T-0.54 | 0.195
T-0.13 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3
-v2 | Black | M 1.25
T 0.70 | M 18
T 22 | 300, 325
350
T-40 | M-0.86
T-0.45 | 0.195
T-0.13 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3
-v3 | Light
Blue | M 1.25
T 0.63 | M 18
T 23 | 300, 325
T-40 | M-0.86
T-0.43 | 0.195
T-0.10 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3
-v4 | Ivory | M 1.49
T 1.06 | M 17
T 19 | 300, 325
350
T-100 | M-1.20
T-0.78 | 0.145
T-0.14 | 14° | 800,
1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
| Type3
-v5 | Yellow | M 1.49
T 0.90 | M 17
T 20 | 300, 325
350
T-100 | M-1.20
T-0.62 | 0.145
T-0.14 | 14° | 800,
1000 | 2.0 | 1.4 | 2.5 | 1.4 (2.5) |
5
| Type3
-v6 | Green | M 1.25
T 0.80 | M 18
T 21 | 300, 325
T-100 | M-0.86
T-0.54 | 0.195
T-0.13 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
|--------------|---------------|------------------|--------------|-------------------|------------------|-----------------|-----|--------------|-----|-----|-----|-----------|
| Type3
-v7 | Black | M 1.25
T 0.70 | M 18
T 22 | 300, 325
T-100 | M-0.86
T-0.45 | 0.195
T-0.13 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type3
-v8 | Light
Blue | M 1.25
T 0.63 | M 18
T 23 | 300, 325
T-100 | M-0.86
T-0.43 | 0.195
T-0.10 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
The Type4 OPU Needles consist of aspiration needles that taper at two locations at the distal tip of the device, with the first taper beginning 70 mm from the tip and the second starting 25 mm from the tip. The table below shows the features of the Type4 OPU Needles.
| Model | Color
of
Hub | Needle
O.D.
(mm)
M: main
T1:
1st Step
Tapered
T2 :
2nd Step
Tapered | Needle
Gauge
M: main
T1:
1st Step
Tapered
T2:
2nd Step
Tapered | Needle
Length
(mm)
M: main
T1:
1st Step
Tapered
T2 :
2nd Step
Tapered | Needle
ID
(mm)
M: main
T2:
2nd Step
Tapered | Wall
Thickness
(mm) | Needle
Bevel
Angle | Connec
tion
Tube
Length
(mm) | Connec
tion
Tube
O.D.
(mm) | Connec
tion
Tube
ID
(mm) | Stopper
Size | Tube size
Compatible
with
Stopper |
|--------------|--------------------|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------|--------------------------|------------------------------------------|----------------------------------------|--------------------------------------|-----------------|--------------------------------------------|
| Type4
-v1 | Green | M-1.25
T1-1.06
T2-0.80 | M-18/
T1-19,
T2-21 | M-300
T1-70
T2-25 | M-0.98
T2-0.54 | 0.135 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type4
-v2 | Black | M-1.25
T1-0.90
T2-0.70 | M-18/
T1-20
T2-22 | M 300
T1-70
T2-25 | M-0.98
T2-0.43 | 0.135 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
| Type4
-v3 | Light
Blue | M-1.25
T1-0.80
T2-0.63 | M-18/
T1-21
T2-23 | M-300
T1-70
T2-25 | M-0.98
T2-0.39 | 0.135 | 14° | 800,
1000 | 2.0 | 1.2 | 2.5 | 1.2 (2.5) |
8. Substantial Equivalence Discussion
The following table compares the indications for use for the subject Kitazato OPU Needles and the predicate device:
| Subject Device | Predicate Device | Comments |
|---|---|---|
| K162881 | K112462 | |
| The Kitazato OPU Needles | ||
| consisting of: | The Kitazato OPU Needles | |
| consisting of: | The intended use of the subject | |
| and predicate devices is the | ||
| same. | ||
| Kitazato OPU Needle with | ||
| Connection Tube (model | ||
| number Type2) Kitazato OPU Reduced Needle | ||
| (model number Type3) Kitazato OPU Two-Stage | ||
| Reduced Needle (model | ||
| number Type4) are intended to obtain oocytes | ||
| from ovarian follicles. | Kitazato OPU Needle with | |
| Connection Tube (model | ||
| number Type2) Kitazato OPU Reduced Needle | ||
| (model number Type3) are intended to obtain oocytes | ||
| from ovarian follicles. |
The following tables compare the technological characteristics of the subject Kitazato OPU Needles to the predicate devices:
6
Type2 OPU Needle Technological Characteristics Comparison
| Parameter | Subject Device
Type2 -OPU Needle
With Connection
Tube
K162881 | Predicate Device
Type2 -OPU Needle
With Connection
Tube
K112462 | Comments | | | | |
|-------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lumen Type | Single | Single | Same | | | | |
| Tapered
Needle | No | No | Same | | | | |
| Device
Materials | Stainless steel (304) | Stainless steel (304) | Same | | | | |
| | ABS | ABS | | | | | |
| | PVC | PVC | | | | | |
| | Silicone | Silicone | | | | | |
| | Polypropylene
Epoxy resin | Polypropylene
Epoxy resin | | | | | |
| Needle
Gauge Range | 16-23 | 16-24 | Similar: The range of needle gauges for the
subject devices is within those of the
predicate devices. | | | | |
| | Needle OD
Range | 0.63-1.65 mm | | 0.55 -1.65 mm | Similar: The range of needle ODs for the
subject devices is within the range of the
predicates. | | |
| | | Needle
Length Range | | 300-350 mm | | 200-350 mm | Different: The predicate devices are offered in
additional sizes that are not available for the
subject devices. These differences do not
raise different questions of Safety and
Effectiveness (S&E) as the range of needle
lengths for the subject devices is within the
range of the predicates. |
| Echogenic
Marker | | | Yes | Yes | | Same | |
| Connection
Tube Length | 800-1000 mm | | 200-1000 mm | Different: The predicate devices are offered in
additional sizes that are not available for the
subject devices. These differences do not
raise different questions of S&E as the range
of tubing lengths for the subject devices are
within the range of the predicates. | | | |
| | Connection
Tube OD | | 2.0 | | 2.0 | Same | |
| | Connection
Tube Fitting | | Silicone stopper
with attached
female connector
for aspiration | | Silicone stopper
with attached
female connector
for aspiration | Same | |
| | | | Sterilization
Method | | Ethylene oxide | | |
| | | | | | | | |
| Single-
Use/Repeat-
Use | | Single-Use | | Single-Use | Same | | |
| MEA | 1-Cell MEA: ≥80%
expanded
blastocysts at 96h | 1-Cell MEA: ≥80%
expanded
blastocysts at 96h | Same | | | | |
| Endotoxin |