The Cook Otrieva™ Tapered Ovum Aspiration Needles are used for laproscopic or ultrasound guided transvaginal aspiration and flushing of oocytes from ovarian follicles.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Otrieva™ Tapered Ovum Aspiration Needle, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with clinical performance metrics as typically expected for algorithmic-based devices.

Therefore, many of the requested sections (2-6, 8-9) are not applicable as this document does not describe an AI/algorithmic device or a study designed to establish clinical performance against predefined acceptance criteria for such a device. Instead, it describes engineering and pre-clinical tests to support substantial equivalence.

Here's the information that can be extracted and inferred from the document:

1. A table of (implied) acceptance criteria and the reported device performance

Since this is a submission to demonstrate substantial equivalence, the "acceptance criteria" are implicitly the performance specifications of the predicate device. The new device must perform at least as well as the predicate device or demonstrate that modifications do not introduce new safety/effectiveness questions.

Characteristic / Implied Acceptance Criteria (based on Predicate Device)	Reported Device Performance (Otrieva™ Tapered Ovum Aspiration Needle)
Material Biocompatibility:	The materials (stainless steel #304, polycarbonate, PTFE, FEP, silicone, copolyester) are standard for medical devices and consistent with or acceptable variations from the predicate device materials.
Sterility:	Sterile (SAL 10⁻⁶) using Ethylene Oxide sterilization.
Endotoxin Level:	USP endotoxin (LAL) tested and passed with 20EU or less per device.
Embryo Biocompatibility (MEA):	Two-cell MEA tested and passed with 80% or greater Blastocyst rate at 72h. (Predicate: 1-cell MEA, 75% or greater blastocyst rate at 96h. The change in test method is noted as acceptable and does not alter safety/effectiveness).
Mechanical Integrity:	Testing confirmed that design modifications had no adverse effect on needle performance for: Resistance to breakage, Air tightness, Tensile strength testing between the tubing and handle junction, and Leakage testing. (Specific metrics for these tests are not provided in the summary).
Shelf Life:	3 years.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes pre-clinical (bench) testing and biocompatibility verification, not a clinical test set from human data for an AI/algorithmic device. The "test set" here refers to device samples used in the non-clinical testing. The document does not specify the number of units tested for each non-clinical test (e.g., how many needles were subjected to "Resistance to breakage testing"). The manufacturer is William A. Cook Australia.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically understood for AI/algorithmic devices does not apply to this type of medical device submission. Biocompatibility and engineering tests do not rely on expert consensus for "ground truth" in the same way.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No human adjudication is described for the non-clinical tests performed.

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

Not applicable. This is not an AI/algorithmic medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithmic medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" implicitly refers to objective measurements and pass/fail criteria defined by engineering standards, biocompatibility regulations (e.g., ISO standards), and internal quality controls. For the Mouse Embryo Assay (MEA), the "ground truth" is the observed blastocyst rate in the tested embryos, which is a biological outcome.

8. The sample size for the training set

Not applicable. This is not an AI/algorithmic medical device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. This is not an AI/algorithmic medical device.

Summary

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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.

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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)

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510(k) Summary - K141365 Otrieva™ Tapered Ovum Aspiration Needle - 14 July 2014

Submitted by:	William A. Cook Australia95 Brandl StreetEight Mile PlainsBrisbaneQueensland4113Australia
Contact:Email:Telephone:Fax:	Katie-Lou BuscherKatie-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 CodeMQE)
Predicate Device	Ovum Pick-Up Aspiration Needle, cleared under K983593
Device Description	This device is intended for laparoscopic or ultrasound guidedtransvaginal aspiration and flushing of oocytes from ovarian folliclesThe needle is passed through a transvaginal ultrasound transducer orplaced through a cannula for a laparoscopic procedure to advance intothe ovarian follicle.The main body of the cannula is 17 gage, which tapers to 20 gage atthe distal tip. Although the outer diameter of the needle tapers, aconstant 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 avacuum tube with a length of 50 cm. The tubing is connected to asilicone 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 forlaparoscopic or ultrasound guided transvaginal aspiration and flushingof 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™ TaperedOvum AspirationNeedle	Ovum Pick-UpAspiration Needle	Comparison
Indication for Use	The Cook Otrieva™Tapered OvumAspiration Needles areused for laparoscopicor ultrasound guidedtransvaginal aspirationand flushing of oocytesfrom ovarian follicles.	The Ovum Pick-UpAspiration Needles areused for aspiration andflushing of oocytes fromovarian follicles.	The Otrieva Indication forUse has the addition ofultrasound andlaparoscopic approachesexplicitly stated. Thepredicate device isintended to be usedlaparoscopically and withtransvaginal ultrasound,as described in thepredicate 510(k)summary, and theseapproaches were alsoincluded in the clearedlabelling for the predicatedevice.This is not a newintended use, as theclinical practise hasalways includedtransvaginal ultrasoundand laparoscopy.
Contraindications	This device should notbe used on a patientwith an active vaginalor intrauterine infection,a sexually transmitteddisease, a recentuterine perforation, arecent caesareansection, or who iscurrently pregnant.	This device should notbe used on a patientwith an active vaginal orintrauterine infection, asexually transmitteddisease, or who iscurrently pregnant.	These patient populationswere added to ensureconsistency with clinicalpractices for in vitrofertilization.
Product Description	Needle passed throughtransvaginal ultrasoundtransducer or placedthrough a cannula for alaparoscopic procedureto advance into theovarian follicle.	Needle passed throughtransvaginal ultrasoundtransducer or placedthrough a cannula for alaparoscopic procedureto advance into theovarian follicle.	The description of theOtrieva™ is substantiallyequivalent to thepredicate device.
Dimensions
Gage	17 G tapering to 20 G	12 G - 20 G	The Otrieva™ TaperedOvum Aspiration Needle
Cannula InnerDiameter	0.60 mm	2.10 mm - 0.60 mm	has an increased wallthickness at the 17 Gproximal portion of the
Needle Length	30 & 35 cm	20 cm - 40 cm
Aspiration TubingLength	90 cm	25cm - 90 cm	needle cannula which isnecessary to ensure anappropriate wallthickness at the distal,tapered end of the needlewhile maintaining a 0.60 mminner diameter.
Device Name	Otrieva™ TaperedOvum AspirationNeedle	Ovum Pick-UpAspiration Needle	Comparison
Aspiration TubingExternal Diameter	1.32 mm	1.67 mm - 2.7 mm(5 Fr - 8 Fr)	The diameter of theOtrieva aspiration tubingis smaller than thepredicate.
Vacuum TubingLength	50 cm	N/A	Vacuum tubing has beenadded to the design of the
Vacuum TubingExternal Diameter	2.06 mm	N/A	Otrieva™ Tapered OvumAspiration 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 beenadded to the design of theOtrieva™ Tapered OvumAspiration Needle
Test Tube Stopper	Silicone	Silicone	Same
Vacuum Line FemaleConical Fitting	Copolyester orPolycarbonate	N/A	Vacuum tubing has beenadded to the design of theOtrieva™ Tapered OvumAspiration Needle
Vacuum Line Cannula	Stainless steel #304	Stainless steel #304	Same
Other characteristics
Lumens	Single	Single or Double	Otrieva™ Tapered OvumAspiration Needle lumentype falls within the rangeof the predicate device
Echo-tip	Echo-Tip only	With or without Echo-Tip	Otrieva™ Tapered OvumAspiration Needle lumentype falls within the rangeof 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
EndotoxinSpecification	USP endotoxin (LAL)tested and passed with20EU or less perdevice	USP Endotoxin (LAL)tested and passed with20EU or less per device	Same
MEA specification	Two-cell MEA testedand passed with 80%or greater Blastocystrate at 72h.	Once cell MEA testedand passed with 75% orgreater Blastocyst at 96h.	MEA test has changedfrom 1-cell MEA (75% orgreater Blastocyst at 96h) to 2-cell MEA (80% orgreater Blastocyst at 72h). Both techniques areacceptable and provideindication of embryotoxicity.
Sterilization Method	Ethylene Oxide	Ethylene Oxide	Same
Packaging	Polyester/low densitypolyethylene film withTyvek-Poly pouch	Tyvek-Poly pouch	Same

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Non-clinical testingsummary	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.

Regulation Number and Section

§ 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).