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 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.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving the device meets them:

The document (K133857) describes the Brella-Spec™ Vaginal Speculum and its substantial equivalence to a predicate device (Depalt Vaginal Speculum 2000 Series and Depalt Lighting System, K072762).

Key Finding: The submission explicitly states: "No clinical studies have been done for the purpose of obtaining safety and effectiveness data." This means the device's acceptance criteria are NOT proven through clinical trials or comparative effectiveness studies with human readers or AI assistance. Instead, acceptance is based on bench testing, biocompatibility testing, sterilization validation, packaging validation, and electrical safety testing to demonstrate substantial equivalence to a predicate device.

Given this, many of the specifics requested (like effect size of AI assistance, number of experts for ground truth, sample sizes for test/training sets, etc.) are not applicable to this submission, as it relies on non-clinical data for clearance.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device in terms of technological characteristics, intended use, and performance, supported by non-clinical testing.

Acceptance Criteria (Implied by Substantial Equivalence Basis)	Reported Device Performance (Summary from text)
Biocompatibility	Tested in accordance with Food and Drug Administration Blue Book Memo, G95-1, and ISO-10993 requirements for limited contact duration, surface contacting, breached mucosal membrane device. Demonstrated to be suitable for intended use.
Sterilization Efficacy	Sterilization method validated and tested in accordance with ISO 11137: -Sterilization of healthcare products-Radiation.
Packaging Integrity	Packaging validated and tested in accordance with ISO 11607: -Packaging for terminally sterile medical devices.
Electrical Safety (for illumination system)	Tested for electrical safety in accordance with IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
Design Specifications Conformity	Verification and validation tests conducted in accordance with Proa Medical, Inc., design control procedures. Tested using established testing procedures to ensure the performance parameters conform to the product design specifications.
Risk Mitigation	ISO 14971: Medical Devices-Application of Risk Management to medical devices was followed to mitigate risks.
Functional Equivalence (to predicate)	- Indications for Use: Same as predicate.- Dimension: Minimal difference, no safety/effectiveness concerns.- Blade Configuration: Triple blades (subject) vs. dual blades (predicate). Claimed to be "more effective because it provides larger vagina-contacting surface and view window," without impact on safety.- Blade Movement: 2 articulating blades move horizontally (subject) vs. 1 articulating blade moves vertically (predicate). Claimed to be "more effective because it provides larger view window," without influencing safety.- Thumb Paddle: 2 thumb paddles (subject) vs. 1 (predicate). Claimed to have "better control" without safety/effectiveness concerns.- View Window: Adjustable area (5.8-31 cm²) (subject) vs. fixed (18 cm²) (predicate). Claimed to be "more flexible and effective without safety concerns."- Illumination System: Same as predicate (built-in LED).- Materials: Different (Polypropylene and Acrylic Polycarbonate for subject vs. Polystyrene for predicate), but biocompatibility testing ensures safety.- Sterility: Sterile (subject) vs. non-sterile (predicate). Claimed to make the subject device "safer."

Study Details (Based on Non-Clinical Data)

Sample size used for the test set and the data provenance:
This information is not specified in the provided text for the bench, biocompatibility, sterilization, packaging, and electrical safety tests. The provenance is internal Proa Medical, Inc. testing, not external patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. Ground truth for non-clinical tests (like material properties, sterilization efficacy, electrical output) is established by adherence to recognized standards (ISO, IEC, FDA Blue Book Memo) and engineering specifications, not by expert consensus in a clinical context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as it pertains to clinical study adjudication, not non-clinical testing.
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, a clinical MRMC study was not done. The document explicitly states: "No clinical studies have been done for the purpose of obtaining safety and effectiveness data." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.
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 device is a manual medical instrument, not an AI or algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" is defined by regulatory standards, engineering specifications, and validated test methods. For example:
- Biocompatibility: Compliance with ISO 10993.
- Sterilization: Compliance with ISO 11137.
- Electrical Safety: Compliance with IEC 60601-1.
- Performance: Conformity to Proa Medical's internal design specifications.
The sample size for the training set:
This is not applicable. No training set was used as this is a physical medical device, not a machine learning model.
How the ground truth for the training set was established:
This is not applicable as there was no training set.

Summary

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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 victoria@proamedical.com

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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Image /page/1/Picture/0 description: The image shows the logo for Proa Medical. The word "Proa" is in a bold, sans-serif font on the top line, with the "P" having a long vertical extension. Below it, "MEDICAL" is written in a similar but slightly smaller font. The entire logo is in black against a white background.

Predicate Device

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

Device Description

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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Image /page/2/Picture/0 description: The image shows the logo for Proa Medical. The word "Proa" is in large, bold, sans-serif font, with each letter connected to the others. Below "Proa" is the word "Medical" in a smaller, sans-serif font, also in bold. The logo is black and white.

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™ VaginalSpeculum	Depalt Vaginal Speculum andDepalt Lighting System
Indications forUse	Same as the predicate	Used for the purposes ofvisualization and exposure of theinterior of the vagina by amedical professional duringgynecological and obstetricalprocedures/ examinations.Depalt Lighting System providesthe light necessary to illuminatethe field duringprocedures/examinations."
Dimension	· Blade (stationary)length 4.5"· Blade (stationary) width1.2"· Handle length 2.5"	· Blade length 4.4"· Blade width 1.1"· Handle length 3"	The difference is minimal;no safety or effectivenessconcerns
Blade	Triple blades (1 stationary,2 articulating)	Dual blades (1 stationary, 1articulating)	The difference does not havean impact on safety of thesubject device. With twoarticulating blades, thesubject device should bemore effective because itprovides larger vagina-contacting surface and viewwindow.
Blademovement	2 articulating blades movehorizontally	1 articulating blade movesvertically	The difference does notinfluence safety of subjectdevice. The subject deviceshould be more effectivebecause it provides largerview window with twoarticulating blades.
Hinge	Same as the predicate	2-hinge system
Thumb paddle	1 on left side, 1 on rightside	1 on back side	The difference does notcause any safety andeffectiveness concerns.Actually the subject deviceshould have better controlwith two thumb paddles
Ratchet teeth	Similar to the predicate	Vertical ratchet teeth
View window	Adjustable area (5.8-31cm²)	Fixed area (18 cm²)	The difference makes thesubject device more flexibleand effective without safetyconcerns
Illuminationsystem	Same as the predicate	Built-in LED light with battery
Materials	Polypropylene and AcrylicPolycarbonate	Polystyrene	The subject and predicatedevices are different inmaterials. However, a fullbattery of biocompatibilitytesting was conducted on thesubject device to ensuresafety
Sterility	Sterile	Non-sterile	The subject device isprovided sterile whereas thepredicate device is not. Thedifference makes the subjectdevice safer
Use life	Same as the predicate	Single-use, disposable

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proa
MEDICAL

. .

K133857 Page 4 of 4

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized emblem featuring a symbol of intertwined lines, possibly representing human services or health-related concepts. The emblem is black and stands out against the white background of the seal.

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 (800) 638-2041 or (301) 796-7100 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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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.4

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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.