The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Device Description

The Jada® System is a 41 cm long intrauterine device primarily made of silicone. The vacuum connector and seal valve are made of polyvinylchloride and acrylonitrilebutadiene-styrene. The device consists of an intrauterine loop on the distal end of a translucent tube. The proximal end of the tube has a vacuum connector for connection to a vacuum tube. Proximal to the connection of the Intrauterine Loop is a donut-shaped cervical seal. The cervical seal is filled with and emptied of 60-120 mL of sterile fluid by attaching a syringe to the seal valve. The intrauterine loop has 20 vacuum pores oriented toward its inside diameter. The outer surface of the intrauterine loop is a silicone shield which overhangs the vacuum pores to protect tissue from vacuum and to prevent the vacuum pores from plugging with tissue and blood clots.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Jada® System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Endpoint)	Performance Goal / Description	Reported Device Performance
Primary Effectiveness Endpoint	Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada® System per the Instructions for Use. (Performance goal was 82.0% success rate, based on a meta-analysis of Bakri Postpartum Balloon literature data).	ITT Cohort: 94.3% (100/106), with a lower bound 95% confidence limit of 88.1%. mITT Cohort: 96.2% (100/104; 95% CI: 90.4%, 98.9%). PP Cohort: 99% (96/97; 95% CI: 94.4% to 100%). (All reported success rates exceed the performance goal of 82.0%.)
Primary Safety Endpoint	Incidence, severity, and seriousness of device-related adverse events.	No adverse events judged definitely related to the device or procedure. Low rate of possibly related adverse events, all anticipated. Five possibly device-related adverse events rated "mild". Three possibly device-related adverse events rated "moderate" (endometritis). No "severe" events.
Mechanical Testing	Verification of various physical and functional attributes (e.g., dimensions, integrity, vacuum performance, flow rate, bond strength). Examples: - Cervical seal withstands 180 mmHg vacuum. - Evacuates 400 mL simulated blood in ≤ 1 minute. - Maintains 70mm diameter for 48 hours.	All mechanical tests performed and verified. (Specific quantitative results for each test are not provided in the summary but were affirmed as met during the review process.)
Biocompatibility Testing	Compliance with ISO 10993-1, including Cytotoxicity, Maximization Sensitization, Vaginal Irritation, Systemic Toxicity, and Material Mediated Pyrogenicity.	All specified biocompatibility tests were conducted. (Results were deemed acceptable, allowing for substantial equivalence determination.)
Sterilization & Shelf-Life Testing	Sterilized to SAL = 10-6 (ISO 11137-2:2013). Shelf-life of 4 years.	Sterilized using gamma radiation to a SAL = 10-6. A shelf-life of 4 years has been established based on real-time aging.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Pivotal Study (effectiveness and safety): 107 subjects enrolled, 106 evaluable.
- Initial pilot study: 10 women.
- Initial phase of pivotal study: 13 women.
Data Provenance:
- Pivotal Study: United States (12 sites in the U.S.), prospective, multicenter, single-arm, open label.
- Initial pilot study: Indonesia.
- Initial phase of pivotal study: Uganda.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" in the traditional sense for the clinical endpoints.

Instead, the primary effectiveness endpoint was externally benchmarked against a meta-analysis of literature data for the Bakri Postpartum Balloon. This implies that the 'ground truth' for setting the performance goal was derived from existing peer-reviewed clinical evidence rather than a panel of experts specifically adjudicating the cases of the Jada® study.

The safety endpoint involved assessing adverse events, which would typically be evaluated by the treating physicians and potentially reviewed by an independent safety committee (DMC/DSMB), but the document does not specify the number or qualifications of such reviewers.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the clinical outcomes within the Jada® System pivotal study.

The study was a "single-arm, open label" design, meaning outcomes were assessed by the study investigators at each site. The performance goal for effectiveness was set based on external literature from the predicate device (Bakri Postpartum Balloon), rather than an internal expert adjudication process for the Jada® study's cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The pivotal study was a single-arm study comparing the Jada® System's performance to a literature-derived performance goal of a predicate device (Bakri Postpartum Balloon). It did not involve human readers interpreting images with and without AI assistance, as would be typical for an MRMC study in an imaging context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Jada® System is a physical medical device (an intrauterine device), not an imaging AI algorithm. Therefore, the concept of "standalone algorithm performance" or "human-in-the-loop performance" in the context of AI is not applicable to this device. The clinical study assessed the device's performance when used by healthcare professionals.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Effectiveness Ground Truth (for performance goal): The performance goal for effectiveness (82.0% success rate) was established based on a meta-analysis of data from literature assessing the performance of the Bakri Postpartum Balloon. This can be considered a form of "outcomes data" derived from existing clinical evidence.
Effectiveness Ground Truth (for Jada® study outcomes): The "control of postpartum hemorrhage" was defined by the avoidance of further non-surgical, second-line, or surgical interventions. This represents demonstrable clinical outcomes data as observed by the treating clinicians in the study.
Safety Ground Truth: Adverse events were reported and classified in terms of incidence, severity, and seriousness, and assessed for their relatedness to the device or procedure. This is also based on clinical outcomes data and assessment by clinicians.

8. The Sample Size for the Training Set

The Jada® System is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. The clinical data serves as the basis for demonstrating safety and effectiveness.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, the concept of a training set and its associated ground truth is not applicable here because the Jada® System is not an AI algorithm.

Summary

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August 28, 2020

Alydia Health % Cindy Domecus, R.A.C. Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010

Re: K201199

Trade/Device Name: Jada® System Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: OQY Dated: July 27, 2020 Received: July 29, 2020

Dear Cindy Domecus:

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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Monica D. Garcia, Ph.D. Acting 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) K201199

Device Name Jada® System

Indications for Use (Describe)

The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K201199

I. SUBMITTER

510(k) Owner Colby Holtshouse Alydia Health 3495 Edison Way Menlo Park, CA 94025 Phone: 650-275-3772 Fax: 415-354-3473 Email: colby@alvdiahealth.com

Submission Correspondent Cindy Domecus, R.A.C. (US & EU) Domecus Consulting Services LLC Phone: (650) 343-4813 Fax: (650) 343-7822 Email: DomecusConsulting@comcast.net

Date Prepared August 28, 2020

II. DEVICE

Name of Device:	Jada® System
Common or Usual Name:	Vacuum-induced Hemorrhage Control
Regulation Name:	Obstetric-Gynecologic Specialized Manual Instrument
Regulation Number:	21 CFR § 884.4530
Regulatory Class:	II
Product Code:	OQY (Intrauterine Tamponade Balloon)

III. PREDICATE DEVICE

The predicate device is the Bakri® Postpartum Balloon, Bakri® Postpartum Balloon with Rapid Instillation Components, K170622. The predicate device has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

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a donut-shaped cervical seal. The cervical seal is filled with and emptied of 60-120 mL of sterile fluid by attaching a syringe to the seal valve. The intrauterine loop has 20 vacuum pores oriented toward its inside diameter. The outer surface of the intrauterine loop is a silicone shield which overhangs the vacuum pores to protect tissue from vacuum and to prevent the vacuum pores from plugging with tissue and blood clots.

Before placing the lada® System device inside the uterus, the intrauterine loop is compressed. The compressed loop is inserted into the uterus transvaginally. The cervical seal is placed within the vagina, at the external cervical os, and inflated. Vacuum is then applied to a maximum value of 90 mmHg until bleeding is controlled. The device should be fixed to the thigh along the tube.

V. INDICATIONS FOR USE
The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.

Attribute	K201199Subject Device:Jada® System	K170622Predicate Device:Bakri® PostpartumBalloonBakri® PostpartumBalloon with RapidInstillationComponents	Comparison
Manufacturer	Alydia Health	Cook Incorporated	N/A
Product Code	OQY	OQY	Same
Indications for Use	The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted.	Bakri® Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.Bakri® Postpartum Balloon with Rapid	Different

VI. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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		InstillationComponents isintended to providetemporarycontrol or reduction ofpostpartum uterinebleeding whenconservativemanagement iswarranted.
Principle ofAction	Inserted into the uterusand establishes avacuum to cause theuterine walls to pressagainst one another,producing a tamponadeof the bleeding vessels	Inserted into the uterusand is inflated to pressoutward on the uterinewalls, producingtamponade of thebleeding vessels	Different
Design	Inflatable cervical sealand intrauterine loopwith vacuum pore	Inflatable uterineballoon and a singledrainage side port	Different
Rx/OTC	Rx	Rx	Same
Materials	Silicone,Polyvinylchloride(PVC), Acrylonitrile-Butadiene-Styrene(ABS)	Silicone	Different
Sterile	SAL 10-6	SAL 10-6	Same
Single-use	Yes	Yes	Same

The Indications for Use statement for the Jada® System is not identical to the predicate device; however, the differences do not alter the intended use of the device. Both the subject and predicate devices have the same intended use for the treatment of abnormal uterine bleeding when conservative management is warranted.

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

. Principle of Operation: The subject device utilizes vacuum to affect tamponade on uterine walls, whereas the predicate device utilizes the fluidic pressure of an expanding balloon to affect tamponade
. Design: The subject device's intrauterine loop has a looped (drain) tube with a series of Vacuum Pores on the inside surface. The intrauterine loop features an elliptical pattern that lays flat on the uterine tissue bed, whereas the

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Alydia Health

predicate device has a single opening drain tube protruding out of the middle of the inflated balloon

. Materials: The patient contacting portions of both devices are made of silicone. However, the subject device includes a seal valve and vacuum connector made of ABS and PVC, respectively. All patient contacting devices are made of silicone for the subject and predicate device.
These differences in technological characteristics do not raise different questions of safety and effectiveness. Non-clinical and clinical data provided by Alydia Health were used to address the differences related to design and principle of operation to demonstrate substantial equivalence to the predicate device.

PERFORMANCE DATA VII.

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

Mechanical Testing

The following mechanical tests were performed:

Cervical Seal and Tube Dimensions: Verification of tube and seal dimensions
. Intrauterine Loop Portion Dimensional Test – Verification of intrauterine loop dimensions
Removal of Intrauterine Portion Test Verification that intrauterine loop and ● shield remain intact during removal
Vacuum Pore Diameter Verification of vacuum pore size ●
No Sharp Edges – Verification of smooth edges and surfaces of device
Attaining Pressure Drop – Verification that cervical seal withstands pressure differential of 180 mmHg vacuum
Static Load Test – Verification that the cervical seal withstands a static load of 1 lb. applied axially along the tube without failure
Overfill Capacity – Verification that cervical seal does not fail when filled with 180 mL water.
. Cervical Seal Inflation – Verification that cervical seal can be filled with 60 mL of water within 30 seconds with 10 lbs. of force on syringe
. Impact Load Test – Verification that the cervical seal withstands an impact test of dropping a 1 lb. weight 2 ft axially along the tube without failure
. Connection Tube Junction Impact Load Test - Verification that the intrauterine loop withstands an impact test of dropping a 1 lb. weight 2 ft axially along the tube without failure
. Flow Rate – Verification that the device with vacuum is able to evacuate 400 mL of simulated blood in 1 minute or less
Device Integrity Leak Test Verification that the joints of the device do not . leak when 180 mmHg of vacuum is applied

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K201199

. Integration to Hospital Vacuum Line – Verification that the device connects to a vacuum tube
Inflation Tube Geometry – Verification that the cervical seal inflation lumen is functional
. Syringe Accommodation – Verification that a luer tapered syringe can be attached to the seal valve
. Cervical Seal Deflation – Verification that cervical seal can be emptied of 60 mL of water within 30 seconds with 10 lbs. of force on syringe
Cervical Seal Diameter and Bond Stability – Verification that the seal maintains a diameter of 70 mm and maintains integrity after 48 hours
Clotted Blood Test Verification that the device can evacuate simulated ● blood in the presence of clotted blood without occluding
Vacuum Connector Bond Test – Verification that the vacuum connector withstands a tensile load of 8.8 lbf
Seal Valve Bond Test – Verification that the seal valve withstands a tensile load of 3.7 lbf

Biocompatibility Testing

The Jada® System is a surface device in contact with a breached surface, with limited duration (< 24 hours).

The biocompatibility evaluation for the Jada® System was conducted in accordance with the FDA June 2016 guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff. The battery of testing included the following tests:

Cytotoxicity (ISO 10993-5:2009) ●
. Maximization Sensitization (ISO 10993-10:2010)
Vaginal Irritation (ISO 10993-10:2010)
Systemic toxicity (ISO 10993-11:2017) ●
. Material Mediated Pyrogenicity (ISO 10993-11:2017)

Sterilization and Shelf-Life Testing

The Jada® System is sterilized using gamma radiation to a SAL = 10-6, according to ISO 11137-2: 2013. A shelf-life of 4 years has been established based on real-time aging.

Clinical Studies

Clinical testing of the Jada® System included an initial pilot study of 10 women in Indonesia, an initial phase of the pivotal study of 13 women in Uganda, and an IDE pivotal study of 107 women in the U.S. Substantial equivalence was based in part on the pivotal study, as described below.

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Pivotal Studv

The pivotal study was a prospective, multicenter, single-arm, open label, literaturecontrolled study at 12 sites in the U.S. A total of 107 subjects were enrolled into the study, of which 106 subjects were evaluable. Study entrance criteria included the following estimated blood loss (EBL) ranges:

Vaginal delivery: 500 – 1500 mL EBL or C-section delivery: 1000 – 1500 mL EBL

Primary Effectiveness Endpoint

The primary effectiveness endpoint was as follows:

Control of postpartum hemorrhage, defined as the avoidance of non-surgical, second-line or surgical intervention to control uterine hemorrhage after the use of the Jada® System per the Instructions for Use.

Non-surgical, second line procedures include uterine balloon therapy, uterine packing, or uterine artery embolization. Surgical intervention includes procedures such as uterine arterial ligation, uterine compression sutures or hysterectomy.

Note: Continuation of the administration of uterotonics concomitant with and post Jada® System use is standard of care and does not constitute failure of the primary effectiveness endpoint.

Primary Safety Endpoint

The primary safety endpoint was the incidence, severity and seriousness of devicerelated adverse events.

Effectiveness Results

The analysis of effectiveness was based on the 106 subjects in the ITT Cohort. Results from the 104 subjects in the mITT and 97 subjects in the PP Cohort are also presented. The treatment success rate in the ITT Cohort was 94.3% (100/106. p<0.001), with a lower bound 95% confidence limit of 88.1%. The success rate performance goal was 82.0% (95% CI: 73.4% to 89.2%), based on a meta-analysis of data from literature assessing the performance of the Bakri Postpartum Balloon. The treatment success rate in the mITT Cohort was 96.2% (100/104; 95% CI: 90.4%, 98.9%). The treatment success rate in the PP Cohort was 99% (96/97; 95% CI: 94.4% to 100%).

Safety Results

There were no adverse events judged definitely related to the device or the procedure and there was a low rate of possibly related adverse events, all of which were anticipated in this patient population and with introduction of an intrauterine device. Five possibly device-related adverse events were rated as "mild" and three were rated as "moderate" without any event in this group rated "severe". The three moderate events were cases of endometritis, which is a known risk of long labor, vaginal exam, and postpartum hemorrhage.

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Summary

In summary, the pivotal trial of the Jada® System demonstrates the device's safety and effectiveness in the treatment of abnormal postpartum uterine bleeding and hemorrhage.

VIII. CONCLUSIONS

The nonclinical and clinical performance data described above demonstrate that the Jada® System is as safe and effective as the predicate device 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.