BRELLA-SPEC(TM) VAGINAL SPECULUM

K133857 · Proa Medical, Inc. · HIB · Apr 28, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K133857
• Device Name: BRELLA-SPEC(TM) VAGINAL SPECULUM
• Applicant: Proa Medical, Inc.
• Product Code: HIB · Obstetrics/Gynecology
• Decision Date: Apr 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The Brella-Spec™ Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.

Device Story

Brella-Spec™ Vaginal Speculum is a sterile, single-use, non-metal device designed for gynecological and obstetrical examinations. It features a triple-blade design (one stationary, two articulating) operated by a manual ratchet mechanism to provide an adjustable view window (5.8-31 cm²). The device incorporates a fully enclosed LED illumination system to light the field of view. Used in clinical settings by medical professionals, the speculum provides visualization and exposure of the vaginal interior. The device is constructed from biocompatible polypropylene and acrylic polycarbonate. It is provided sterile in a PETG tray with a Tyvek lid. The device benefits patients by providing improved visualization and access during procedures compared to traditional specula.

Clinical Evidence

No clinical studies were conducted. Evidence is based on bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11137), packaging validation (ISO 11607), and electrical safety (IEC 60601-1).

Technological Characteristics

Materials: Polypropylene and acrylic polycarbonate. Design: Triple-blade (1 stationary, 2 articulating) with manual ratchet. Illumination: Integrated LED system. Sterilization: Radiation (ISO 11137). Packaging: Sterile PETG tray with Tyvek lid. Electrical safety: IEC 60601-1 compliant.

Indications for Use

Indicated for visualization and exposure of the vagina by medical professionals during gynecological and obstetrical procedures and examinations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Depalt Vaginal Speculum 2000 Series and Depalt Lighting System (K072762)

Submission Summary (Full Text)

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APR 2 8 2014

510(k) Summary

Applicant: Proa Medical, Inc. . 2512 Artesia Blvd. Suite 305C Redondo Beach, CA 90278-3269 United States Contact: Victoria Nadershahi 1-800-899-3385 [e-mail]

| Date Summary Prepared: | April 24th, 2014 |
|------------------------|---------------------------------------------|
| Trade Name: | Brella-SpecTM Vaginal Speculum |
| Common or Usual Name: | Speculum, Vaginal, Nonmetal |
| Device Class: | Class II |
| Classification Code: | HIB |
| Classification Name: | 21 CFR 884.4530 Speculum, Vaginal, Nonmetal |

## Device Intended Use

The Brella-Spec™ Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.

Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.

## Device Indications for use

·

The Brella-Spec"M Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.

Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the ficid during procedures and examinations.

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## Predicate Device

- Depalt Vaginal Speculum 2000 Series and Depalt Lighting System cleared for marketing under a) 510(k) notification number K072762.
## Device Description

The Brella-Spec™ Vaginal Speculum is a sterile, single-use device with built-in LED illumination system to provide optimal visualization and access during gynecological and obstetrical procedures. This speculum was designed to provide visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. The device is ergonomically designed to maximize the view window using two side blades that are opened by a manually operated ratchet mechanism. The device incorporates a fully enclosed LED illumination system. It is composed of medical grade, biocompatible plastic materials.

#### Technological Characteristics

The Brella-Spec™ Vaginal Speculum has substantially equivalent technological characteristics and the same indications for use as the predicate device Depalt Vaginal Speculum 2000 Series and Depalt Lighting System. The use of polypropylene and acrylic polycarbonate along with providing the device in sterile PETG tray and Tyvek lid does not introduce any new concerns regarding safety or effectiveness. The design has been demonstrated as substantially equivalent using bench test data.

## Performance Data

The Brclla-Spec™ Vaginal Speculum has been tested for biocompatibility in accordance with the Food and Drug Administration Blue Book Memo, G95-1, use of international standard ISO-10993 Requirements for limited contact duration, surface contacting, breached mucosal membrane device and are demonstrated to be suitable for the intended use of this product. The sterilization method for the Brella-Spec™ Vaginal Speculum has been validated and tested in accordance with ISO 11137: -Sterilization of healthcare products-Radiation. The packaging for the Brella-Spec"M Vaginal Speculum has been validated and tested in accordance with ISO 11607-Packaging for terminally sterile medical devices. In addition, the Brolla-Speculum has been tested for electrically safety in accordance with IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

Verification and validation tests were conducted in accordance with Proa Medical, Inc., design control procedures. The Brella-Speculum was tested using established testing procedures to ensure the performance parameters conform to the product design specifications. ISO 14971- Medical Devices-Application of Risk Management to medical devices was followed to mitigate risks that may be. associated with the device.

No clinical studies have been done for the purpose of obtaining safety and effectiveness data.

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# Substantial Equivalence

The Brella-Spec™ Vaginal Speculum has substantially equivalent technological characteristics and the same indications for use as the predicate Depart Vaginal Speculum 510(k) K072762. The differences in the design features do not have an impact on safety and effectiveness of the subject device.

| Parameter | Subject device (K133857) | Predicate device (K072762) | Differences |
|------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Brella-Spec™ Vaginal<br>Speculum | Depalt Vaginal Speculum and<br>Depalt Lighting System | |
| Indications for<br>Use | Same as the predicate | Used for the purposes of<br>visualization and exposure of the<br>interior of the vagina by a<br>medical professional during<br>gynecological and obstetrical<br>procedures/ examinations.<br>Depalt Lighting System provides<br>the light necessary to illuminate<br>the field during<br>procedures/examinations." | |
| Dimension | · Blade (stationary)<br>length 4.5"<br>· Blade (stationary) width<br>1.2"<br>· Handle length 2.5" | · Blade length 4.4"<br>· Blade width 1.1"<br>· Handle length 3" | The difference is minimal;<br>no safety or effectiveness<br>concerns |
| Blade | Triple blades (1 stationary,<br>2 articulating) | Dual blades (1 stationary, 1<br>articulating) | The difference does not have<br>an impact on safety of the<br>subject device. With two<br>articulating blades, the<br>subject device should be<br>more effective because it<br>provides larger vagina-<br>contacting surface and view<br>window. |
| Blade<br>movement | 2 articulating blades move<br>horizontally | 1 articulating blade moves<br>vertically | The difference does not<br>influence safety of subject<br>device. The subject device<br>should be more effective<br>because it provides larger<br>view window with two<br>articulating blades. |
| Hinge | Same as the predicate | 2-hinge system | |
| Thumb paddle | 1 on left side, 1 on right<br>side | 1 on back side | The difference does not<br>cause any safety and<br>effectiveness concerns.<br>Actually the subject device<br>should have better control<br>with two thumb paddles |
| Ratchet teeth | Similar to the predicate | Vertical ratchet teeth | |
| View window | Adjustable area (5.8-31<br>cm²) | Fixed area (18 cm²) | The difference makes the<br>subject device more flexible<br>and effective without safety<br>concerns |
| Illumination<br>system | Same as the predicate | Built-in LED light with battery | |
| Materials | Polypropylene and Acrylic<br>Polycarbonate | Polystyrene | The subject and predicate<br>devices are different in<br>materials. However, a full<br>battery of biocompatibility<br>testing was conducted on the<br>subject device to ensure<br>safety |
| Sterility | Sterile | Non-sterile | The subject device is<br>provided sterile whereas the<br>predicate device is not. The<br>difference makes the subject<br>device safer |
| Use life | Same as the predicate | Single-use, disposable | |

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proa
MEDICAL

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K133857 Page 4 of 4

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2014

Proa Medical, Inc. Victoria Nadershahi RA/OA Manager 2512 Artesia Blvd. Suite 305C Redondo Beach, CA 90278

Re: K133857

> Trade/Device Name: Brella-Spec Vaginal Speculum Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: March 26, 2014 Received: March 27, 2014

Dear Victoria Nadershahi,

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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Page 2 -- Victoria Nadershahi

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 (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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R Fisher -S

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Slatement on last page.

510(k) Number (if known)

K133857

Device Name

Brella-Spec Vaginal Speculum

Indications for Use (Describe)

Brella-Spec Vaginal Speculum is used for visualization and exposure of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.

Brella-Spec Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.

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 EDA USE ONLY = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

| Benjamin R. Fisher S. |
|----------------------------|
| 2014.04.28 14:54:22+04'00' |

FORM FDA 3881 (1/14)

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