The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6 French in diameter to access the uterine cavity for assessment of tubal patency.

The Selective Salpingography Catheter is intended to be used through a uterine access device and positioned at the tubal ostium for injection of contrast medium for fluoroscopic evaluation of tubal patency.

Device Description

The IAB and SSG Catheters facilitate access to the uterus and tubal ostium to deliver contrast media during diagnostic procedures.

The IAB Catheter is 9 French (Fr) in diameter and has a 23 cm working length. It is designed with a polyurethane shaft and a silicone distal balloon with a 2-cc inflation volume. The catheter includes two lumens, one for balloon inflation and the other can be used to inject contrast medium into the uterus for hysterosalpingography (HSG) and as an access channel that accepts devices up to 6 Fr in diameter for use in assessing tubal patency. The Intrauterine Access Balloon Catheter is packaged with a shipping stylet and a 3 mL syringe that is used to inflate the balloon with sterile media.

The SSG Catheter is manufactured from braided polyethylene and is designed with an angled distal tip with a radiopaque tungsten band. The catheter is 5.5 Fr in diameter and has a 40 cm working length. The SSG Catheter is intended to be used through a dimensionally compatible access catheter (IAB Catheter) to gain access to the uterine cavity for a more selective visualization of the fallopian tubes when positioned at the tubal ostium.

Both devices are supplied sterile (ethylene oxide) and are intended for single-use only.

AI/ML Overview

The provided document focuses on the K181770 510(k) submission for the Intrauterine Access Balloon Catheter and the Selective Salpingography Catheter, demonstrating substantial equivalence to predicate devices. It does not contain information about a study proving device meets acceptance criteria in the manner described in the request, such as a clinical study with a test set, expert ground truth, multi-reader, multi-case study, or standalone algorithm performance.

However, the document does list performance data from bench studies that were conducted to ensure reliable design and performance, with predetermined acceptance criteria being met. This implies that the device does meet specific acceptance criteria based on these bench tests.

Here is the information extracted from the document regarding the acceptance criteria and the "studies" (bench performance tests) that prove the device meets them:

Acceptance Criteria and Reported Device Performance

Note: The document describes "predetermined acceptance criteria" rather than specifying precise quantitative values for each. The reported performance indicates that these criteria were met.

Acceptance Criteria Category	Specific Test/Performance Characteristic	Reported Device Performance
General	Sterilization validation	Met per ISO 11135-1:2014
	Ethylene oxide residual	Met per ISO 10993-7:2008(R)2012
	Transportation simulation	Met per ASTM D4169-16
	Package integrity (dye penetration)	Met per ASTM F1929-15 after 3 years real-time aging
	Package integrity (seal strength)	Met per ASTM F88/F88M-15 after 3 years real-time aging
	Biocompatibility (cytotoxicity)	Met per ISO 10993-5:2009
	Biocompatibility (sensitization)	Met per ISO 10993-10:2010
	Biocompatibility (irritation)	Met per ISO 10993-10:2010
IAB Catheter Specific	Shelf-life	Supported for two years
	Compatibility (with other components)	Met (dimensional compatibility)
	Compatibility (with SSG Catheter)	Met (dimensional compatibility)
	Tensile strength (junctions)	Peak load value greater than predetermined criterion
	Lumen patency	Lumen was patent; predetermined acceptance criteria met
	Balloon leakage and integrity	Met predetermined acceptance criteria; no leakage
	Balloon burst volume	Met predetermined acceptance criteria; burst above labeled volume
	Dimensional accuracy (critical dimensions)	Met acceptance criteria
	Check-Flo valve leak reduction	Met predetermined acceptance criteria for leakage reduction
SSG Catheter Specific	Shelf-life	Supported for three years
	Compatibility (with IAB Catheter)	Dimensional compatibility assessed and met
	Compatibility (with 0.039-inch wire guides)	Dimensional compatibility assessed and met
	Tensile strength (junctions)	Peak load value greater than predetermined criteria
	Lumen patency	Lumen was patent; predetermined acceptance criteria met
	Torque response	Met acceptance criterion (per Cook's internal procedures)
	Radiopacity of marker band	Determined to be radiopaque in a simulated clinical setting
	Kink radius	Adequately characterized
	Dimensional accuracy (critical dimensions)	Met acceptance criteria

The remaining requested information pertains to clinical performance studies, which are not detailed in this 510(k) submission as no such studies were needed for substantial equivalence based on the provided document. The document lists bench performance studies as the primary evidence.

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

Not applicable / Not provided for the device. The document describes bench performance studies (e.g., tensile testing, lumen patency, balloon integrity). These are laboratory tests on device units, not tests on clinical patient data. Therefore, concepts like "test set" in the clinical sense, "data provenance," "country of origin," or "retrospective/prospective" do not apply.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. The device performance was assessed against engineering specifications and industry standards in bench testing, not against expert clinical ground truth.

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

Not applicable / Not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective assessments, which were not part of the described bench performance 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 study was not done. This type of study is for AI/human-in-the-loop performance, which is not relevant to this medical device submission.

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 submission is for a physical medical device, not an AI algorithm.

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

Engineering specifications, industry standards, and internal procedures served as the "ground truth" or reference for the bench performance tests. For instance, material properties (tensile strength), dimensional tolerances, and functional requirements (balloon integrity, lumen patency) were assessed against predefined, objective criteria.

8. The sample size for the training set

Not applicable / Not provided. No "training set" in the context of machine learning or clinical data was mentioned or used for this device. The bench tests involved samples of manufactured devices.

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

Not applicable / Not provided. As there was no training set in the clinical or AI context, no ground truth needed to be established for it. The "ground truth" for the device's acceptable performance was established by engineering design specifications, relevant ISO standards, ASTM standards, and Cook's internal procedures.

Summary

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March 29, 2019

Cook Incorporated Ian Herrman Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

Re: K181770

Trade/Device Name: Intrauterine Access Balloon Catheter, Selective Salpingography Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: February 27, 2019 Received: February 27, 2019

Dear Ian Herrman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts -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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Indications for Use

510(k) Number (if known) K181770

Device Name Intrauterine Access Balloon Catheter

Selective Salpingography Catheter

Indications for Use (Describe)

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)

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510(k) Summary K181770

Intrauterine Access Balloon Catheter Selective Salpingography Catheter Date Prepared: March 26, 2019

Submitted By:

Cook Incorporated Applicant: Contact: Ian Herrman, Rohini Patel Applicant Address: Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Device Information:

Trade Name:

Common Name: Regulation Number: Regulation Name: Product Code: Device Classification:
Phone: (812) 335-3575 x104034 Fax: (812) 332-0281

Intrauterine Access Balloon Catheter Selective Salpingography Catheter Hysterosalpingography Catheters 21 CFR §884.4530 Obstetric-gynecologic specialized manual instrument LKF, Cannula, Manipulator/Injector, Uterine Class II

Predicate Devices:

The predicate device for the Intrauterine Access Balloon (IAB) Catheter is the Advanced Catheter for SHG and SIS cleared under K123258 by Catheter Research Inc.

The predicate device for the Selective Salpingography (SSG) Catheter is the Fallopian Tube Catheterization Set cleared under K171604 by Cook Incorporated.

Device Description:

The IAB and SSG Catheters facilitate access to the uterus and tubal ostium to deliver contrast media during diagnostic procedures.

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Both devices are supplied sterile (ethylene oxide) and are intended for single-use only.

Indications for Use:

Intrauterine Access Balloon Catheter:

The Intrauterine Access Balloon Catheter is used for delivery of contrast medium into the uterine cavity during hysterosalpingography (HSG) for examination of the uterus and fallopian tubes, and evaluation of tubal patency. The catheter lumen accepts catheters up to 6.0 French in diameter to access the uterine cavity for assessment of tubal patency.

Selective Salpingography Catheter:

Comparison to Predicate Devices:

IAB Catheter:

DeviceCharacteristics	Subject DeviceK181770 – IABCatheter	Predicate DeviceK123258 – AdvanceCatheter for HSGand SIS	Comparison
Indications forUse	The IntrauterineAccess BalloonCatheter is used fordelivery of contrastmedium into theuterine cavity duringhysterosalpingography(HSG) forexamination of theuterus and fallopiantubes, and evaluationof tubal patency. Thecatheter lumen acceptscatheters up to 6French in diameter toaccess the uterine	The intended use of "the advance catheterfor HSG and SIS" isfor the delivery ofcontrast media orsaline duringhysterosalpingogram(HSG) and salineinfusionsonogysterography(SIS) into the femalereproductive tract forexamination of theuterus and/or fallopiantubes.	Different: The IABCatheter and thepredicate device areintended for injection ofcontrast media for HSGto evaluate the femalereproductive tract. Thepredicate device can alsobe used for SISprocedures, which thesubject device is not.This differencerepresents a more limiteduse of the device for onlyHSG procedures anddoes not impact the
DeviceCharacteristics	Subject DeviceK181770 – IABCatheter	Predicate DeviceK123258 – AdvanceCatheter for HSGand SIS	Comparison
	cavity for assessmentof tubal patency.	The following aresome clinicalindications: suspectedpolyps, fibroids,adhesions, orendometrialthickening, and/orselective evaluation offallopian tube patency.	overall intended use ofthe device.The IAB Catheter is alsoindicated for introductionof catheters used toassess tubal patencythrough its lumen. Theability to pass a secondcatheter through the IABCatheter does notrepresent a new intendeduse as the overall use isthe same (assessment ofpatency/structuralanomalies in the uterusand fallopian tubes).
General Design	Dual lumen catheterwith an inflatableballoon at its distal tipfor sealing the cervix.The catheter has twoconnection lines, onewith a check valve forballoon inflation andanother with astopcock for contrastmedia infusion. Thesame lumen used forcontrast mediuminfusion can also beused as an access portfor up to 6 Fr devicesused to assess tubalpatency.	Dual lumen catheterwith an inflatableballoon at distal tip forsealing the cervix. Thecatheter has twoconnection lines, onewith a stopcock forballoon inflation andanother with a Leurlock for contrastmedia/saline infusion.Device also has anintroduction sheaththat aids passage of theHSG/SIS catheter intothe uterus.	Different: The predicateincludes an additionalintroduction sheath to aidin delivery of theHSG/SIS catheter to theuterine cavity. Thesubject device does notinclude an introductionsheath, which is notneeded to access theuterine cavity. Thisdifference does not raisedifferent S&E questions.The subject device canbe used for passage ofdimensionallycompatible catheters intothe uterine cavity that areused to assess tubalpatency, which is not afeature of the predicatedevice. This additionaluse does not raise
DeviceCharacteristics	Subject DeviceK181770 - IABCatheter	Predicate DeviceK123258 – AdvanceCatheter for HSGand SIS	Comparison
Materials	PolyurethaneAcetalPolycarbonateHDPEVinyl tubingSilicone
Catheter Length	23 cm	Length unknown	Different: The length ofthe predicate device isnot known. Differencesin length of devices donot raise is differentquestions of S&E. Notethat other cleared deviceshave comparable lengths.
CatheterDiameter	9 Fr	5 Fr and 7 Fr	Different: The subjectdevice has a largerdiameter than thepredicate device. Thisdifference does not raisedifferent questions ofS&E. Note that othercleared devices havecomparable or largerdiameters.
Cervix SealingBalloon	Yes	Same	Same
DeviceCharacteristics	Subject DeviceK181770 - SSGCatheter	Predicate DeviceK171604 – FallopianTube CatheterizationSet	Comparison
Indications forUse	The SelectiveSalpingographyCatheter is intendedto be used through auterine access deviceand positioned at thetubal ostium forinjection of contrastmedium forfluoroscopicevaluation of tubalpatency.	The Fallopian TubeCatheterization Set isintended to be usedthrough a uterineaccess device forfluoroscopic selectivecatheterization of theproximal fallopiantube(s) and injection ofcontrast medium in theevaluation of tubalpatency.	Different: The subjectand predicate indicationsare comparable with theexception that the subjectdevice is only used toaccess the tubal ostium,while the predicate can beused for selectivecatheterization of thefallopian tubes. Thisdifference represents amore limited use of thesubject device, but doesnot impact the overallintended use of the device(assessment of tubalpatency).
General Design	Catheter with acurved tip and aradiopaque band forvisualization. It alsoincludes a Luerconnection forinstallation of contrastmedia.A dimensionallyappropriate wireguide may be used toaid placement of thecatheter.	The predicate deviceincludes a TorqueControl Catheter, aninjection catheter, andthree wire guides.The Torque ControlCatheter is comparableto the subject device. Itconsists of a catheterwith a curved tip and aLuer connection forinstallation of contrastmedia.	Different: The predicatedevice includes additionalcomponents needed tocomplete catheterizationof the proximal fallopiantubes.The design of the subjectdevice and the TorqueControl Catheter arecomparable and are bothused to access the tubalostium to assess tubalpatency.
DeviceCharacteristics	Subject DeviceK181770 - SSGCatheter	Predicate DeviceK171604 – FallopianTube CatheterizationSet	Comparison
			These differences do notraise different questionsof S&E.
Materials	PolyethyleneStainless SteelRhenium-tungstenradiopaque band	Torque ControlCatheter:PolyethyleneStainless Steel	Different: Materials usedin the subject andpredicate devices are thesame except for themarker band on thesubject device. Thisdifference does not raisedifferent questions ofS&E.
Catheter Length	40 cm	50 cm	Different: The predicateis 10 cm longer than thesubject device. Thedifference in length doesnot raise differentquestions of S&E as thelength of this catheteronly needs to be longenough to pass through adimensionally acceptableuterine access catheterand have sufficient lengthto reach the tubal ostium.
CatheterDiameter	5.5 Fr	Same	Same

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As shown above, the indications for use of the subject IAB Catheter is not identical to the predicate device; however, the differences do not represent a new intended use as both devices

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are used to deliver contrast medium for the assessment of patency/structural anomalies in the uterus and fallopian tubes.

Regarding technological characteristics, the subject and predicate devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., dimensions, materials, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.

SSG Catheter:

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As shown above, the indications for use of the subject SSG Catheter is not identical to the predicate device; however, the differences do not represent a new intended use as both devices are used to deliver contrast medium for the assessment of patency of the fallopian tubes.

Regarding technological characteristics, the subject and predicate devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., dimensions, materials, additional components, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.

Performance Data:

The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. These tests include:

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. Sterilization validation testing per ISO 11135-1:2014
Ethylene oxide residual testing per ISO 10993-7:2008(R)2012 .
. Transportation simulation testing per ASTM D4169-16
Package integrity testing after real-time aging to three years: ●
- o Dye penetration testing per ASTM F1929-15
- Seal strength testing per ASTM F88/F88M-15 o
. Biocompatibility studies, as follows:
- o Cytotoxicity testing per ISO 10993-5:2009
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 O
- O Intracutaneous irritation testing per ISO 10993-10:2010
Bench Performance studies for the IAB Catheter before and after aging demonstrated ● that all predetermined acceptance criteria were met in the following tests and support a shelf-life of two years:
- Compatibility testing The set components to be used together as stated in the o instructions for use were tested for dimensional compatibility. The same testing was completed to assure the compatibility of the SSG Catheter with the IAB Catheter.
- Tensile testing Tensile testing was completed for the different junctions of the O device. Testing demonstrated that that the peak load value was greater than the predetermined acceptance criterion.
- Lumen patency Lumen patency of the device was completed via injection of O media. Testing demonstrated that the IAB Catheter lumen was patent and the predetermined acceptance criteria were met.
- Balloon leakage and integrity The balloon was tested for leakage and integrity O under the conditions of expected use. Testing demonstrated that the devices met the predetermined acceptance criteria for integrity and did not display leakage.
- Balloon burst The balloon was tested for burst volume. Testing demonstrated O that the predetermined acceptance criteria were met and the balloon burst above the labeled volume.
- Dimensional testing Testing was completed to verify the devices critical O dimensions (working length, length of side arm adapters, catheter outer diameter). Testing demonstrated that the acceptance criteria were met.
- Check-Flo valve leak reduction The Check-Flo valve was tested to show a O reduction in leakage under conditions of expected use. Testing demonstrated that the device met the predetermined acceptance criteria for leakage reduction.
Bench Performance studies for the SSG Catheter before and after aging demonstrated ● that all predetermined acceptance criteria were met in the following tests and support a shelf-life of three years:
- o The SSG Catheter was tested to assure dimensional compatibility with the IAB Catheter when used according to its intended use. Dimensional

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compatibility was also assessed to support use with 0.039 inch diameter wire guides.

Tensile testing Tensile testing was completed for the different junctions of o the device. Testing demonstrated that that the peak load value was greater than the predetermined acceptance criteria.
Lumen patency Lumen patency of the device was completed via injection of o media. Testing demonstrated that the SSG Catheter lumen was patent and the predetermined acceptance criteria were met.
Torque response The catheter was tested for adequate torque response. o Acceptance criterion was determined by Cook's internal procedures. Testing demonstrated that the acceptance criterion was met.
Radiopacity of marker band Testing demonstrated that the subject device o was determined to be radiopaque in a simulated clinical setting.
Kink radius A characterization study was completed to find the kink radius o for the SSG Catheter tip. Testing adequately characterized the kink radius.
o Dimensional testing Testing was completed to verify the SSG Catheter critical dimensions (working length, catheter outer diameter). Testing demonstrated that the acceptance criteria were met.

Conclusion:

The results of the performance testing described above demonstrates that the subject devices are as safe and effective as the predicate devices and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.4530 Obstetric-gynecologic specialized manual instrument.

(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.