EpiStat is intended for use by physicians and trained obstetrics/gynecology nurse practitioners during episiotomy repair procedures. EpiStat is intended to temporarily tamponade the post partum discharge of fluids from the vagina in order to assist with the episiotomy repair procedure.

V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.

Device Description

EpiStat is an inflatable balloon tamponade device designed to provide a safe and effective method of temporarily tamponading the vagina to assist with post partum episiotomy repair. EpiStat is provided sterile in peel-open packages and intended for onetime use.

V-Stat is an inflatable balloon tamponade device designed to provide a safe and effective method of achieving haemostatic control by direct or indirect compression of vaginal tissues as a result of the inflation of a balloon using air. V-Stat is provided sterile in peelopen packages and intended for one-time use.

AI/ML Overview

The EpiStat & V-Stat Vaginal Tamponade Balloon is a Class I and Class II medical device, respectively, and its premarket notification 510(k) summary does not contain the level of detail typically found in studies for AI/ML-powered devices. The provided document concerns a traditional medical device (tamponade balloons) seeking substantial equivalence to existing predicate devices, rather than a novel AI/ML application. Therefore, many of the requested categories related to AI/ML device studies, such as ground truth, expert adjudication, MRMC studies, and training set details, are not applicable or cannot be extracted from this document.

However, based on the provided text, here's what can be gathered regarding acceptance criteria and performance for the EpiStat & V-Stat Vaginal Tamponade Balloon:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance	Comments
Mechanical Performance	Balloon burst strength	Successfully completed performance testing.	Demonstrated that the device "consistently performed within its design parameters." Specific quantitative thresholds for burst strength are not provided in this summary.
	Tensile strength	Successfully completed performance testing.	Demonstrated that the device "consistently performed within its design parameters." Specific quantitative thresholds for tensile strength are not provided in this summary.
	Leak testing	Successfully completed performance testing.	Demonstrated that the device "consistently performed within its design parameters." Specific quantitative criteria for leak rate are not provided.
Packaging & Sterilization	Packaging qualification	Successfully completed performance testing.	In compliance with internationally recognized standards. No specific metrics or thresholds are provided.
	Sterilization	Successfully completed performance testing.	In compliance with internationally recognized standards. No specific metrics or thresholds are provided.
Biocompatibility	Biocompatibility testing	Successfully completed performance testing in compliance with ISO 10993-1.	This indicates the device materials are safe for biological contact. Specific test results (e.g., cytotoxicity, sensitization) are not detailed.
Functional Equivalence	Indications for Use (EpiStat)	Intended for temporary tamponade of post partum discharge during episiotomy repair.	Stated to be "substantially equivalent to the National Hospital Packaging, Vag Packing" in terms of indications for use and functional effectiveness.
	Indications for Use (V-Stat)	Intended for temporary haemostatic control following vaginal surgery (e.g., post-operative packing, brisk intraoperative bleeding control).	Stated to be "substantially equivalent to the National Hospital Packaging, Vag Packing" in terms of indications for use and functional effectiveness.
Design & Operation	General design, materials, and principles of operation.	Incorporates the same general design, materials, and principles of operation used in other inflatable balloon tamponade devices.	Substantially equivalent to predicate devices.
	Physical construction, principle of operation, deployment methodology.	Employs the same physical construction, principle of operation, and deployment methodology (inflated using air) as the Cook OB/GYN Tamponade Uterine Balloon Catheter Set and Boston Medical Products Epi-Stop Epistaxis Catheter.	Substantially equivalent to predicate devices.
Manufacturing Quality	Manufacturing controls	Device will be manufactured according to specified process controls and in compliance with an ISO 9001/ISO 13485 Quality Assurance Program.	This is a commitment to quality manufacturing, not a direct performance test result.

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 the performance tests (burst strength, tensile strength, leak testing, etc.).
The data provenance is not specified. The tests are described as "Performance Testing" which implies an in-house or contracted laboratory setting, rather than clinical data from human subjects.

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)

This information is not applicable and not provided in the document. The "ground truth" for a mechanical device is typically established by engineering specifications and objective physical measurements rather than expert human interpretation.

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

This information is not applicable and not provided in the document. Adjudication methods are relevant for subjective assessments, particularly in clinical studies or image interpretation, which are not described here.

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

This information is not applicable and not provided. An MRMC study is relevant for AI/ML image interpretation or diagnostic tools, which this device is not.

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

This information is not applicable and not provided. This device is a physical medical instrument, not an algorithm.

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

For the performance tests, the "ground truth" is based on objective engineering and manufacturing specifications and established industry standards (e.g., ISO 10993-1 for biocompatibility). There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the device's physical and biological performance attributes.

8. The sample size for the training set

This information is not applicable and not provided. The device is a physical tamponade balloon, not an AI/ML system requiring a training set.

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

This information is not applicable and not provided for the reasons stated above.

Summary

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FrontLine
Medical

EpiStat & V-Stat Vaginal Tamponade Balloon Premarket Notification 510(k)

JUL - 7 2006

510(k) Summary

(1) Submitter's Name / Contact Person:	Frontline Medical, Innovation Works, National Technology Park, Castletroy, Limerick, Ireland
Contact Person:	Paul Slattery, Chief Technical Officer Tel: (011) 35387 4184183
(2) Device Name:
Trade Name:	EpiStat Vaginal Tamponade Balloon V-Stat Vaginal Tamponade Balloon
Common Name:	Vaginal Packing
Classification Name:	Obstetric-Gynecological general manual instrument
Device Classification:	Class I, 21 CFR §884.4520

(3) Identification of Predicate Devices:

#	Manufacturer	Device	510(k) No.
1	National HospitalPackaging	Vag Packing	None (Class I)
2	Cook OB/GYN	Tamponade Uterine BalloonCatheter Set	K013597
3	Boston Medical Products	Epi-Stop Epistaxis Catheter	K972077

(4) Description of the Device:

(5) Statement of Intended Use:

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FrontLine
Medical

(6) Predicate Device Comparison:

EpiStat and V-Stat are substantially equivalent to the National Hospital Packaging, Vag Packing (listed on December 16, 1992) in terms of its indications for use and functional effectiveness. EpiStat and V-Stat incorporate the same general design, materials and principles of operation used in other inflatable balloon tamponade devices. The EpiStat and V-Stat are substantially equivalent to the Cook OB/Gyn, SOS Bakri Balloon Tamponade (K013597 cleared for marketing by the Center on April 17, 2002) in terms of its physical construction and principle of operation and employs the same deployment methology and method of operation (inflated using air) as the Boston Medical Products Epi-Stop Epistaxis Catheter (K972077 cleared for marketing on June 26, 1997). The device will be manufactured according to specified process controls and in compliance with an ISO 9001/ISO 13485 Quality Assurance Program. The device will undergo packaging and sterilization procedures in compliance with internationally recognized standards. Being similar with respect to indications for use, materials and physical construction to predicate devices, the device meets the requirements for section 510(k) substantial equivalence.

(7) Performance Testing:

Performance testing involving balloon burst strength, tensile strength, leak testing, packaging qualification, sterilization and biocompatibility testing in compliance with ISO 10993-1 has been successfully completed. The successful tests demonstrated the EpiStat/V-Stat device consistently performed within its design parameters, is safe and effective and performs as well as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a bird in flight or a symbolic representation of human services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL - 7 2006

Mr. Paul Slattery Chief Technical Officer Frontline Medical, Innovation Works National Technology Park Limerick IRELAND

Re: K060289

Trade/Device Name: V-Stat™ Vaginal Tamponade Ballon and Epistat™ Vaginal Tamponade Ballon Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: KNA Dated: June 23, 2006 Received: June 26, 2006

Dear Mr. Slattery:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "ISO6-2006" at the top and "Centennial" in the middle. The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial".

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Page 2 -

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. 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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FrontLine Medical	EpiStat & V-Stat Vaginal Tamponade BalloonPremarket Notification 510(k)
-------------------	-----------------------------------------------------------------------------

Indications for Use

510(k) Number (if known):	K060289
Device Name:	Epistat Vaginal Tamponade Balloon

Indications for Use: EpiStat is intended for use by physicians and trained
obstetrics/gynecology nurse practitioners during episiotomy repair procedures.
EpiStat is intended to temporarily tamponade the post partum discharge of fluids
from the vagina in order to assist with the episiotomy repair procedure.

Prescription Use(Per 21 CFR 801 Subpart D)	X	AND/OR	Over the Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANTOHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)Division of Reproductive, Abdominal,and Radiological Devices510(k) Number	K060289
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ﻟﻠﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﻘﻠﻌﺔ ﺍﻟﻤ

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Indications for Use

510 (k) Number (if known): K060289

Device Name: V-Stat Vaginal Tamponade Balloon

Indications for Use: Indications for Use: V-Stat is intended for use by physicians for temporary haemostatic control following vaginal surgery procedures such as (a) post operative packing for posterior and anterior vaginal repairs (b) brisk introperative bleeding during urethral sling procedures and post operative packing to control sub-pubic haematoma following urethral sling procedures.

Prescription Use X (Pcr 21 CFR 801 Subpart D) AND/OR Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Torin A. Syson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) 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.