(151 days)
No
The device description and performance studies focus on the mechanical properties and function of an inflatable balloon tamponade device, with no mention of AI or ML technologies.
Yes.
The devices are used to provide temporary tamponade or haemostatic control to assist with medical procedures and post-operative care, which aligns with the definition of a therapeutic device designed to treat or manage a medical condition.
No
The devices described (EpiStat and V-Stat) are intended for therapeutic purposes (tamponading fluid discharge, achieving hemostatic control) rather than for diagnosing a condition or disease.
No
The device description explicitly states that both EpiStat and V-Stat are "inflatable balloon tamponade devices," which are physical hardware components. The performance studies also focus on physical properties like burst strength and tensile strength.
Based on the provided information, neither EpiStat nor V-Stat are IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- EpiStat and V-Stat are physical devices used within the body (in the vagina) to provide temporary mechanical support (tamponade or haemostatic control). They do not analyze biological samples.
Their intended use and device descriptions clearly indicate they are used for physical intervention during or after surgical procedures, not for diagnostic testing of biological specimens.
N/A
Intended Use / 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.
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.
Product codes
KNA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians and trained obstetrics/gynecology nurse practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
None (Class I), K013597, K972077
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| 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 Hospital | ||
| Packaging | Vag Packing | None (Class I) | |
| 2 | Cook OB/GYN | Tamponade Uterine Balloon | |
| Catheter Set | K013597 | ||
| 3 | Boston Medical Products | Epi-Stop Epistaxis Catheter | K972077 |
(4) Description of the Device:
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.
(5) Statement of Intended 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.
1
| FrontLine |
|---|
| Medical |
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.
(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.
2
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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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
4
| FrontLine Medical | EpiStat & V-Stat Vaginal Tamponade Balloon
Premarket 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) |
| ------------------------------------------------ | --- | -------- | ------------------------------------------------ |
|---|
(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 Devices
| 510(k) Number | K060289 |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------- |
ﻟﻠﻤﺴﺎﻋﺪﺓ ﺍﻟﻤﺘﻘﻠﻌﺔ ﺍﻟﻤ
4-1
5
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