The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.

Device Description

The Uterine ElevatOR PRO with OccludOR Balloon™ is a sterile, single-use medical device used to manipulate the uterus and cervix in surgical and diagnostic procedures. The device includes an insulated and anatomically designed stainless steel shaft with an intrauterine balloon and reference graduations (centimetres) at the proximal [to patient] end and an external handle at the distal end. The intrauterine balloon is inflated with air using a standard syringe (not included). The device has a vaginal cup that is pushed along the shaft to support a green cervical cup. The cervical cup provides a guide for colpotomy. There are four sizes of cervical cups available, 32mm, 37mm, and 40mm, which correspond to the different model numbers. A locking assembly secures the position of the vaginal cup and therefore the cervical cup. Sites for suturing are located on the cervical cup. An Occluder Balloon further reduces leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the "Uterine ElevatOR PRO with OccludOR Balloon™", not an AI/ML device. Therefore, the request for acceptance criteria and study details related to AI/ML device performance (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable.

The document describes performance data for a physical medical device, which includes:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that "In all testing, the subject device met the pre-specified acceptance criteria." However, it does not provide a specific table detailing each acceptance criterion and the corresponding reported device performance. It lists the types of tests conducted:

Test Category	Specific Tests Performed	Reported Performance
Biocompatibility	- Cytotoxicity per ISO 10993-5:2009- Irritation per ISO 10993-10:2010- Sensitization per ISO 10993-5:2010- Acute Systemic toxicity per ISO 10993-11:2017- Pyrogenicity per ISO 10993-11 and USP <151>	"The subject device is considered externally communicating device & surface contact device that may come in contact with tissue and breached or compromised surface respectively for a duration of less than 24 hours." "met the pre-specified acceptance criteria."
Performance & Mechanical	- Intrauterine balloon integrity & concentric inspection- Intrauterine balloon inflation stability test for a defined time period.- Intrauterine balloon burst test- Intrauterine balloon fatigue test- Intrauterine balloon adhesion strength test- OccludOR balloon outer diameter inspection & leakage free test- OccludOR balloon deflation time test- OccludOR balloon capacity test- reliability/safety- OccludOR balloon fatigue durability test- OccludOR balloon burst test- Vaginal cup air leakage test- Cervical cup temperature test- Air inflation valve test- Dye-injection port compliance & leakage test- Thumb screw strength test- Locking force test of vaginal cup- Ease of movement of vaginal cup along the shaft- Cervical cup detachment force test- Cervical cup stopper adhesion strength test- Device tensile strength- Handle joint strength- Tip deflection- Ultrasonic welding strength	"In all testing, the subject device met the pre-specified acceptance criteria."

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

The document does not specify sample sizes for any of the tests, nor does it provide information on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in full study reports, not a 510(k) summary.

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, as this is a physical medical device and not an AI/ML device relying on "ground truth" derived from expert consensus. The "truth" for this device's performance is determined by meeting physical and biological specifications through various standard engineering and biocompatibility tests.

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

Not applicable for a physical medical device as described.

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, as this is a physical medical device and not an AI/ML device involving human readers or AI assistance.

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

Not applicable, as this is a physical medical device without an algorithm component.

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

Not applicable for a physical medical device. The "ground truth" here is adherence to engineering specifications and biocompatibility standards.

8. The sample size for the training set:

Not applicable, as this is a physical medical device and not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set or AI/ML model for this physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 31, 2022

The O R Company Pty Ltd Nicole Conway Quality Assurance & Regulatory Affairs Manager 1/32 Silkwood Rise Carrum Downs, Victoria 3201 Australia

Re: K220202

Trade/Device Name: Uterine ElevatOR PRO with OccludOR Balloon™ Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: January 28, 2022 Received: February 3, 2022

Dear Nicole Conway:

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 and Part 809); 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220202

Device Name

Uterine ElevatOR PRO with OccludOR Balloon TM

Indications for Use (Describe)

The Uterine ElevatOR PRO with OccludOR Balloon™ is indicated for manipulation of the uterus, and injection of fluids or gases during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectorny, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperioneum during laparoscopic procedures by sealing the vagina once colpotomy is performed.

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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Image /page/3/Picture/1 description: The image is a logo for "THE O.R. COMPANY". The words "THE" and "COMPANY" are in a blue sans-serif font, with "O.R." in a blue circle. Below the company name is the tagline "The smart way to operate".

Image /page/3/Picture/2 description: The image shows the logo for Symmetry Surgical Company. The logo features a stylized red and gray shape to the left of the text. The text reads "symmetry surgical" in a gray sans-serif font, with the word "company" in a smaller font size to the right.

Image /page/3/Picture/3 description: The image shows the word "Bovie" in a sans-serif font. The word is in a dark blue color. Above the word is a light blue curved line with a dot at the end. The registered trademark symbol is to the right of the word.

Uterine ElevatOR PRO with OccludOR Balloon™ - 510(k) Summary

l. SUBMITTER

The O R Company Pty Ltd 1/32 Silkwood Rise, Carrum Downs, VIC 3201, Australia Phone: +61 3 9413 5555 Fax: + 61 3 9413 5556

Contact Person: Nicole Conway Email: nicole@theorcompany.com Date Prepared: January 19, 2022

II. DEVICE

Trade Name: Uterine ElevatOR PRO with OccludOR Balloon™ Model numbers: UE-OBPRO-32, UE-OBPRO-35, UE-OBPRO-37 and UE-OBPRO-40 Common Name: Uterine Manipulator / Injector Regulation Number: 21 CFR 884.4530 Classification Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF

III. PREDICATE DEVICE

Conmed Corporation, VCARE (Vaginal-Cervical Ahluwalia's Retractor-Elevator), K142716

This predicate has not been subject to a design-related recall.

Reference devices:

Coopersurgical, Inc., Koh Colpotomizer System, K954311

IV. DEVICE DESCRIPTION

Asia Pacific

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Image /page/4/Picture/0 description: The image shows the logo for Symmetry Surgical Company. The logo features the words "symmetry surgical" in a sans-serif font, with the word "company" in a smaller font size to the right. To the left of the text is a red and gray graphic element.

Image /page/4/Picture/2 description: The image shows the logo for "THE O.R. COMPANY". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".

leakage of pneumoperitoneum during laparoscopic surgery. A port at the distal end of handle provides a channel for injection of fluids or gases.

V. INDICATIONS FOR USE

Attributes	Uterine ElevatORPRO withOccludOR BalloonK220202	VCARE® Vaginal-Cervical-Ahluwalia's-Retractor-Elevator K142716	Discussion
Manufacturer	The O R Company PtyLtd	CONMEDCorporation	---
Class	II	II	Same
Regulation Number	884.4530	884.4530	Same
Regulation Generic Name	Cannula,Manipulator/Injector,Uterine	Cannula,Manipulator/Injector,Uterine	Same
Indications for Use	The Uterine ElevatORPRO with OccludORBalloon™is indicatedfor manipulation ofthe uterus, andinjection of fluids orgasses duringlaparoscopicprocedures includingtotal laparoscopichysterectomy,laparoscopic assistedvaginalhysterectomy,laparoscopic tubalocclusion, anddiagnosticlaparoscopy. TheUterine ElevatORPRO with OccludORBalloon™ maintainspneumoperitoneumduring laparoscopic	The ConMed VCARE®Retractor/Elevator isindicated formanipulation of theuterus and injectionof fluids or gasesduring laparoscopicprocedures such asLaparoscopicAssisted VaginalHysterectomy(LAVH), TotalLaparoscopicHysterectomy (TLH),minilap, laparoscopictubal occlusion, ordiagnosticlaparoscopy and alsomaintainspneumoperitoneumby sealing the vaginaonce a colpotomy isperformed.	Same
	procedures bysealing the vaginaonce colpotomy isperformed.
Sterile	Yes, Ethylene Oxide	Yes, Ethylene Oxide	Same
Prescription Use	Yes	Yes	Same
Single Use	Yes	Yes	Same
Intrauterine Balloon inflation volume	7 – 10 сс	7 – 10 сс	Same
Intrauterine Balloon inflation method	The intrauterineballoon is inflated bypassing air from asyringe through apilot balloon locatedat the distal end ofthe device. Inflationis maintained by aone-way valvepositioned in thepilot balloon. Thepilot balloon alsoserves as an indicatorof intrauterineballoon inflation.	The intrauterineballoon is inflated bypassing air from asyringe through apilot balloon locatedat the distal end ofthe device. Inflationis maintained by aone-way valvepositioned in thepilot balloon. Thepilot balloon alsoserves as an indicatorof intrauterineballoon inflation.	Same
Occluder Balloon	Yes	No	Different
Mode of action	Mechanical devicepositioning prior toperforming indicatedlaparoscopicprocedures	Mechanical devicepositioning prior toperforming indicatedlaparoscopicprocedures	Same
Rigid, insulated and anatomicallycurved shaft	Yes	Yes	Same
Handle at the distal [to patient] end	Yes	Yes	Same
Intrauterine balloon at proximal end[to patient] end	Yes	Yes	Same
Intrauterine balloon material	PVC	PVC	Same
Device Components	Direct patientcontacting:Plug capIntrauterine BalloonIntrauterine BalloonColorantHeat-shrink on theshaftStopper on the shaftGraduation markingCervical cup	Direct patientcontacting:Intrauterine BalloonIntrauterine BalloonColorantHeat-shrink on theshaftStopper on the shaftGraduation markingCervical cupVaginal Cup	Similar
	OccludOR balloonOccludOR ballooninflation lineNon-contacting:ShaftThumbscrew &locking assemblyThumbscrew &locking assemblycolorantHandlePilot balloonAir inflation valveAir Inflation lineDye Injection portDye Injection portcapRobert ClampInflation port forOccludOR balloon	Non-contacting:ShaftThumbscrew &locking assemblyThumbscrew &locking assemblycolorantHandlePilot balloonAir inflation valveAir Inflation lineDye Injection portDye Injection portcap
Anatomical site	MucosalMembranes- Uterusand Vagina	MucosalMembranes- Uterusand Vagina	Same
Contact Period	Short-term contact(≤24 hours)	Short-term contact(≤24 hours)	Same

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

Asia Pacific

T +61 3 9413 5555 F +61 3 9413 5556

North America

USA

3034 Owen Drive T +1 800-251-3000 Antioch TN, 37013 F +1 800-342-3272

Contact

info@theorcompany.com theorcompany.com

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Image /page/5/Picture/0 description: The image shows the logo for "THE O.R. COMPANY". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".

Image /page/5/Picture/1 description: The image shows the logo for Asymmetry. The logo consists of the letter A followed by a stylized letter S. The letter S is split into two parts, with the top part being gray and the bottom part being red. The word "symmetry" is written in gray to the right of the letter S.

symmetry surgical" company

vie.

Asia Pacific

T +61 3 9413 5555
F +61 3 9413 5556

North America

3034 Owen Drive
Antioch TN, 37013
USA

T +1 800-251-3000
F+1 800-342-3272

Contact

info@theorcompany.com theorcompany.com

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Image /page/6/Picture/0 description: The image is a logo for "THE O.R. COMPANY". The company name is in blue font, with the "O.R." in a blue circle. Below the company name is the tagline "The smart way to operate".

Image /page/6/Picture/1 description: The image shows the logo for Symmetry Surgical. The logo consists of the letter "A" followed by a stylized "S" made up of two curved shapes, one red and one gray. To the right of the logo is the text "symmetry surgical" in a gray sans-serif font.

Both the subject and predicate devices are sterile, single-use medical devices used to manipulate the uterus and cervix in surgical and diagnostic procedures. At a high level, the subject and predicate devices are based on the following same technological elements:

An anatomically contoured shaft. ●
An intrauterine balloon at the proximal [to patient] end, a handle at the distal end. ●
A cervical cup and a vaginal cup.
. A locking mechanism to secure the vaginal cup in position.
An inflation line for the intrauterine balloon.
A dye injection port at the distal end of the handle. ●

The following technological differences exist between the subject and predicate devices:

The subject device includes the OccludOR Balloon, which is similar to a feature of ● the Colpo-Pneumo Occluder device cleared under K954311.
These differences do not raise different questions of safety and effectiveness as compared to the predicate.

Asia Pacific

3201, Australia

1/32 Silkwood Rise T +61 3 9413 5555

USA

3034 Owen Drive T +1 800-251-3000 Antioch TN, 37013 F +1 800-342-3272 Contact

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Image /page/7/Picture/0 description: The image shows the logo for "THE O.R. COMPANY". The "O.R." is inside of a blue circle. Below the company name is the tagline "The smart way to operate".

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1: 2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The subject device underwent the following tests:

Cytotoxicity per ISO 10993-5:2009
Irritation per ISO 10993-10:2010
Sensitization per ISO 10993-5:2010
Acute Systemic toxicity per ISO 10993-11:2017
Pyrogenicity per ISO 10993-11 and USP <151>

The subject device is considered externally communicating device & surface contact device that may come in contact with tissue and breached or compromised surface respectively for a duration of less than 24 hours.

Performance & mechanical testing

The following performance and mechanical tests demonstrated that the subject device performs substantially equivalent to the predicate device:

Intrauterine balloon integrity & concentric inspection ●
Intrauterine balloon inflation stability test for a defined time period.
Intrauterine balloon burst test
Intrauterine balloon fatigue test ●
Intrauterine balloon adhesion strength test ●
OccludOR balloon outer diameter inspection & leakage free test
OccludOR balloon deflation time test
OccludOR balloon capacity test- reliability/safety
OccludOR balloon fatigue durability test
OccludOR balloon burst test
Vaginal cup air leakage test
Cervical cup temperature test
Air inflation valve test
Dye-injection port compliance & leakage test
Thumb screw strength test
Locking force test of vaginal cup
Ease of movement of vaginal cup along the shaft ●
Cervical cup detachment force test
Cervical cup stopper adhesion strength test ●

Asia Pacific

North A

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Image /page/8/Picture/0 description: The image shows the logo for "The O.R. Company". The letters "O.R." are inside of a blue circle. Below the company name is the tagline "The smart way to operate".

symmetry surgical" company

. Device tensile strength
. Handle joint strength
. Tip deflection
Ultrasonic welding strength

In all testing, the subject device met the pre-specified acceptance criteria.

Conclusion:

The intended use of the subject device is identical to the predicate device. The subject device has similar technological characteristics to the predicate device. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness. All testing undertaken to demonstrate substantial equivalence of the subject device meet the predetermined acceptance criteria. The test results demonstrate that the subject device is as safe and effective as the predicate device.

Asia Pacific

North America

3034 Owen Drive Antioch TN, 37013 USA

T +1 800-251-3000 F +1 800-342-3272 Contact

info@theorcompany.com theorcompany.com

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.