(76 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical needle and associated tubing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is an aspiration needle used for retrieving oocytes, which is a diagnostic or procedural tool, not a treatment.
No
This device is used for the aspiration and flushing of oocytes, which is a therapeutic or procedural action, not for diagnosing a condition.
No
The device description clearly details physical components such as needles, tubing, and a silicone bung, indicating it is a hardware medical device.
Based on the provided information, the Cook Otrieva™ Tapered Ovum Aspiration Needle is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the aspiration and flushing of oocytes from ovarian follicles for procedures like IVF. This is a surgical/procedural device used in vivo (within the body) to collect biological material.
- Device Description: The description details a needle and tubing system designed for physical aspiration and flushing. It does not describe any components or functions related to testing or analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of samples, or providing diagnostic information based on testing biological specimens.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The Otrieva™ needle is a tool for collecting the specimen, not for performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Cook Otrieva™ Tapered Ovum Aspiration Needles are used for laproscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.
Product codes (comma separated list FDA assigned to the subject device)
MQE
Device Description
This device is intended for laparoscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles
The needle is passed through a transvaginal ultrasound transducer or placed through a cannula for a laparoscopic procedure to advance into the ovarian follicle.
The main body of the cannula is 17 gage, which tapers to 20 gage at the distal tip. Although the outer diameter of the needle tapers, a constant 0.60 mm internal diameter is maintained.
The Otrieva™ needles are available in two lengths: 30cm and 35cm. The needles are provided with an aspiration tube of 90 cm length and a vacuum tube with a length of 50 cm. The tubing is connected to a silicone bung.
The materials used in the device include: stainless steel, polycarbonate, PTFE, silicone, FEP and copolyester.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
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)
The Otrieva™ Tapered Ovum Aspiration Needle has undergone non-clinical testing to verify the design modifications did not affect the performance of the needle. The testing included
Resistance to breakage testing
Air tightness testing
Tensile strength testing between the tubing and handle junction
Leakage testing
The design modifications were shown to have no adverse effect on the needle performance in any of these tests.
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.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
William A. Cook Australia Pty, Ltd. Katie-Lou Buscher Project Manager, Regulatory Affairs 95 Brandl Street Brisbane Technology Park, Eight Mile Plains Brisbane, QLD 4113 AUSTRALIA
Re: K141365 Trade/Device Name: Otrieva™ Tapered Ovum Aspiration Needle Regulation Number: 21 CFR& 884.6100 Regulation Name: Assisted Reproduction Needles Regulatory Class: II Product Code: MQE Dated: July 14, 2014 Received: July 15, 2014
Dear Katie-Lou Buscher,
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 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 P. Lerner -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141365
Device Name
Otrieva™ Tapered Ovum Aspiration Needle
Indications for Use (Describe)
The Cook Otrieva™ Tapered Ovum Aspiration Needles are used for laproscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary - K141365 Otrieva™ Tapered Ovum Aspiration Needle - 14 July 2014
| Submitted by: | William A. Cook Australia
95 Brandl Street
Eight Mile Plains
Brisbane
Queensland
4113
Australia |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:
Email:
Telephone:
Fax: | Katie-Lou Buscher
Katie-Lou.Buscher@CookMedical.com
+61 7 3841 1188
+61 7 3841 1288 |
| Trade name | Otrieva™ Tapered Ovum Aspiration Needle |
| 510(k) Number | K141365 |
| Classification name | Assisted Reproduction Needles (21 CFR 884.6100, Product Code
MQE) |
| Predicate Device | Ovum Pick-Up Aspiration Needle, cleared under K983593 |
| Device Description | This device is intended for laparoscopic or ultrasound guided
transvaginal aspiration and flushing of oocytes from ovarian follicles
The needle is passed through a transvaginal ultrasound transducer or
placed through a cannula for a laparoscopic procedure to advance into
the ovarian follicle.
The main body of the cannula is 17 gage, which tapers to 20 gage at
the distal tip. Although the outer diameter of the needle tapers, a
constant 0.60 mm internal diameter is maintained.
The Otrieva™ needles are available in two lengths: 30cm and 35cm.
The needles are provided with an aspiration tube of 90 cm length and a
vacuum tube with a length of 50 cm. The tubing is connected to a
silicone bung.
The materials used in the device include: stainless steel, polycarbonate,
PTFE, silicone, FEP and copolyester. |
| Indication for Use | The Cook Otrieva™ Tapered Ovum Aspiration Needles are used for
laparoscopic or ultrasound guided transvaginal aspiration and flushing
of oocytes from ovarian follicles. |
| Comparison to | The Otrieva™ Tapered Ovum Aspiration Needle is a modification of the |
| Predicate Device | Ovum Pick-up Aspiration Needle (K983593). The modifications are:
• Incorporation of a tapered cannula instead of fixed diameter cannula - the tapered cannula is designed to allow the clinician the rigidity of a larger diameter cannula while providing a smaller diameter tip for puncture. As the inner and outer diameter of the cannula at both ends falls within the range of the predicate device, and the internal lumen of the cannula is the same as the predicate device, this change does not represent a new technology that could raise new types of safety or effectiveness questions. |
| | • Addition of a 50 cm vacuum line - the addition of the vacuum line simply provides an extension of the connection to the vacuum source and does not change the use of the device. Attachment of an Ovum Aspiration Needle to the vacuum source using tubing is not a new technology and therefore there are no new safety or effectiveness questions raised. |
| | • Incorporation of a smaller (1.32 mm) diameter aspiration tube – The smaller diameter aspiration tube is applied to better match the inner lumen of the needle cannula. This modification is not a new technology and does not raise new types of safety or effectiveness questions. |
| | In addition to the modifications described above, the Indication for Use statement has been modified from the predicate device to include transvaginal ultrasound and laparoscopic approaches, both of which were specifically stated within the instructions for the predicate device, just not stated directly within the Indications for Use statement. This modification to the Indication for Use statement does not impact safety and efficacy of the device. |
| | The Mouse Embryo Assay (MEA) specification has changed from one-cell (75% or greater blastocyst rate at 96 h) to 2-cell (80% or greater blastocyst rate at 72 h). This is a change in performance specification, and does not represent a new technology, therefore the safety and effectiveness is not altered. |
| | A full comparison is provided in Table 1 over the page. |
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Table 1 - Comparison of Otrieva and predicate device
| Device Name | Otrieva™ Tapered
Ovum Aspiration
Needle | Ovum Pick-Up
Aspiration Needle | Comparison |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Cook Otrieva™
Tapered Ovum
Aspiration Needles are
used for laparoscopic
or ultrasound guided
transvaginal aspiration
and flushing of oocytes
from ovarian follicles. | The Ovum Pick-Up
Aspiration Needles are
used for aspiration and
flushing of oocytes from
ovarian follicles. | The Otrieva Indication for
Use has the addition of
ultrasound and
laparoscopic approaches
explicitly stated. The
predicate device is
intended to be used
laparoscopically and with
transvaginal ultrasound,
as described in the
predicate 510(k)
summary, and these
approaches were also
included in the cleared
labelling for the predicate
device.
This is not a new
intended use, as the
clinical practise has
always included
transvaginal ultrasound
and laparoscopy. |
| Contraindications | This device should not
be used on a patient
with an active vaginal
or intrauterine infection,
a sexually transmitted
disease, a recent
uterine perforation, a
recent caesarean
section, or who is
currently pregnant. | This device should not
be used on a patient
with an active vaginal or
intrauterine infection, a
sexually transmitted
disease, or who is
currently pregnant. | These patient populations
were added to ensure
consistency with clinical
practices for in vitro
fertilization. |
| Product Description | Needle passed through
transvaginal ultrasound
transducer or placed
through a cannula for a
laparoscopic procedure
to advance into the
ovarian follicle. | Needle passed through
transvaginal ultrasound
transducer or placed
through a cannula for a
laparoscopic procedure
to advance into the
ovarian follicle. | The description of the
Otrieva™ is substantially
equivalent to the
predicate device. |
| Dimensions | | | |
| Gage | 17 G tapering to 20 G | 12 G - 20 G | The Otrieva™ Tapered
Ovum Aspiration Needle |
| Cannula Inner
Diameter | 0.60 mm | 2.10 mm - 0.60 mm | has an increased wall
thickness at the 17 G
proximal portion of the |
| Needle Length | 30 & 35 cm | 20 cm - 40 cm | |
| Aspiration Tubing
Length | 90 cm | 25cm - 90 cm | needle cannula which is
necessary to ensure an
appropriate wall
thickness at the distal,
tapered end of the needle
while maintaining a 0.60 mm
inner diameter. |
| Device Name | Otrieva™ Tapered
Ovum Aspiration
Needle | Ovum Pick-Up
Aspiration Needle | Comparison |
| Aspiration Tubing
External Diameter | 1.32 mm | 1.67 mm - 2.7 mm
(5 Fr - 8 Fr) | The diameter of the
Otrieva aspiration tubing
is smaller than the
predicate. |
| Vacuum Tubing
Length | 50 cm | N/A | Vacuum tubing has been
added to the design of the |
| Vacuum Tubing
External Diameter | 2.06 mm | N/A | Otrieva™ Tapered Ovum
Aspiration Needle |
| Materials | | | |
| Needle Cannula | Stainless Steel #304 | Stainless Steel #304 | Same |
| Needle Hub | Polycarbonate | Polycarbonate | Same |
| Aspiration Tubing | PTFE | PTFE | Same |
| Vacuum Tubing | FEP | N/A | Vacuum tubing has been
added to the design of the
Otrieva™ Tapered Ovum
Aspiration Needle |
| Test Tube Stopper | Silicone | Silicone | Same |
| Vacuum Line Female
Conical Fitting | Copolyester or
Polycarbonate | N/A | Vacuum tubing has been
added to the design of the
Otrieva™ Tapered Ovum
Aspiration Needle |
| Vacuum Line Cannula | Stainless steel #304 | Stainless steel #304 | Same |
| Other characteristics | | | |
| Lumens | Single | Single or Double | Otrieva™ Tapered Ovum
Aspiration Needle lumen
type falls within the range
of the predicate device |
| Echo-tip | Echo-Tip only | With or without Echo-Tip | Otrieva™ Tapered Ovum
Aspiration Needle lumen
type falls within the range
of the predicate device |
| Shelf Life | 3 years | 3 years | Same |
| Single Use/Reusable | Single Use | Single Use | Same |
| Sterility | Sterile (SAL 10-6) | Sterile (SAL 10-6) | Same |
| Endotoxin
Specification | USP endotoxin (LAL)
tested and passed with
20EU or less per
device | USP Endotoxin (LAL)
tested and passed with
20EU or less per device | Same |
| MEA specification | Two-cell MEA tested
and passed with 80%
or greater Blastocyst
rate at 72h. | Once cell MEA tested
and passed with 75% or
greater Blastocyst at 96
h. | MEA test has changed
from 1-cell MEA (75% or
greater Blastocyst at 96
h) to 2-cell MEA (80% or
greater Blastocyst at 72
h). Both techniques are
acceptable and provide
indication of embryo
toxicity. |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Same |
| Packaging | Polyester/low density
polyethylene film with
Tyvek-Poly pouch | Tyvek-Poly pouch | Same |
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| Non-clinical testing
| summary | The Otrieva™ Tapered Ovum Aspiration Needle has undergone non-clinical testing to verify the design modifications did not affect the performance of the needle. The testing included Resistance to breakage testing Air tightness testing Tensile strength testing between the tubing and handle junction Leakage testing |
|---|---|
| The design modifications were shown to have no adverse effect on the needle performance in any of these tests. | |
| Safety and Efficacy | The results of the testing provide reasonable assurance that the Otrieva™ Tapered Ovum Aspiration Needle is as safe and effective as the predicate device and support a determination of substantial equivalence. |