(113 days)
The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.
The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair. The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly.
The provided text describes a submission for a medical device called the Glenveigh Vaginal Repair Balloon Catheter. However, it does not include the detailed information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
- Type of Device: The Glenveigh Vaginal Repair Balloon Catheter is a physical medical device (an obstetric-gynecologic specialized manual instrument). Your questions (e.g., about test sets, ground truth, experts, MRMC studies, standalone algorithm performance, training sets) are typically relevant for software-as-a-medical-device (SaMD) or devices incorporating AI/ML, which analyze data (like images) to provide diagnostic or prognostic information.
- Nature of the Submission: This document is a 510(k) summary of safety and effectiveness, seeking clearance based on substantial equivalence to a predicate device. For physical devices, substantial equivalence is often established through manufacturing specifications, material biocompatibility, and functional bench testing.
- "Performance Data" Section: The text states, "Design verification performance test results demonstrate that the Glenveigh Vaginal Repair Balloon Catheter performs its intended use and is equivalent to the predicate device." This typically refers to engineering tests (e.g., burst pressure, inflation/deflation rates, material strength, biocompatibility), not clinical studies with human readers or AI algorithms evaluating data.
Therefore, based on the provided text, I cannot answer your specific questions relating to acceptance criteria and a study as typically understood for AI/ML-driven medical devices. The document does not contain information about:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or similar metrics. The "performance data" mentioned refers to functional equivalence testing.
- Sample sizes for test sets or data provenance. No such clinical or dataset-based testing is described.
- Number or qualifications of experts for ground truth. Not applicable in this context.
- Adjudication method. Not applicable.
- MRMC comparative effectiveness study. Not conducted for this type of device according to the document.
- Standalone algorithm performance. No algorithm is described.
- Type of ground truth used. Not applicable.
- Training set size. No training set is applicable.
- How ground truth for the training set was established. Not applicable.
Summary of what is available in the text related to "performance" and "acceptance":
- Device Function: "temporarily blocks the flow of fluids to assist in episiotomy/laceration repair."
- Performance Claim: Bench testing demonstrated the device is "functionally equivalent to predicate EpiStat/V-Stat Vaginal Tamponade Balloon, and that any minor differences do not affect safety or effectiveness."
- Biocompatibility: "materials that come in direct contact with the patient have a long history of use in medical use and are biocompatible according to ISO 10993."
- Conclusion: "Based on the performance testing, it can be concluded that the Glenveigh Vaginal Repair Balloon Catheter is equivalent to the predicate EpiStat/V-Stat Vaginal Tamponade Balloon with respect to intended use and technological characteristics."
The "acceptance criteria" for this device would likely be successful completion of these functional and biocompatibility tests, demonstrating equivalence to the predicate device, rather than diagnostic accuracy metrics.
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SUMMARY OF SAFETY & EFFECTIV
Image /page/0/Picture/1 description: The image shows the logo for Glenveigh. The logo consists of a stylized, abstract swirl above the word "Glenveigh". The word "Glenveigh" is written in a serif font, and there is a trademark symbol after the word.
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
APR 1 4 2010
| APPLICANT | Glenveigh Surgical, LLC401 Chestnut Street, Suite 230Chattanooga, TN 37402Rick ProctorTel: 423-243-3460Fax: 423-634-8080Email: rick.proctor@glenveigh.com |
|---|---|
| OFFICIALCorrespondent | Penny Northcutt, RAC, CQARegulatory Consultant for Glenveigh SurgicalREGSolutions, LLCTel: 678-428-6978Fax: 678-513-0937Email: pennynorthcutt@theregsolutions.com |
| TRADE NAME: | Glenveigh Vaginal Repair Balloon Catheter |
| CLASSIFICATIONNAME: | Obstetric-Gynecologic Specialized Manual Instrument |
| DEVICECLASSIFICATION | Class II per 21 CFR §884.4530 |
| AND PRODUCTCODE | Product Code: KNA |
| PREDICATEDEVICE NAME | EpiStat/V-Stat Vaginal Tamponade Balloon (K060289)Cleared July 7, 2006Gauze Packing |
SUBSTANTIAL EQUIVALENCE:
The Glenveigh Vaginal Repair Balloon Catheter is substantially equivalent to the EpiStat/V-Stat Vaginal Tamponade Balloon cleared under K060289.
Both the Glenveigh Vaginal Repair Balloon Catheter and the predicate devices have the same method of operation, to temporarily block the flow of fluids to assist in episiotomy/laceration repair.
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Bench testing has demonstrated that the Glenveigh Vaginal Repair Balloon Catheter is functionally equivalent to predicate EpiStat/V-Stat Vaginal Tamponade Balloon, and that any minor differences do not affect safety or effectiveness.
DESCRIPTION OF THE DEVICE:
The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair.
The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly.
INDICATIONS FOR USE:
The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.
PERFORMANCE DATA:
The Glenveigh Vaginal Repair Balloon Catheter materials that come in direct contact with the patient have a long history of use in medical use and are biocompatible according to ISO 10993. Design verification performance test results demonstrate that the Glenveigh Vaginal Repair Balloon Catheter performs its intended use and is equivalent to the predicate device.
CONCLUSION:
Based on the performance testing, it can be concluded that the Glenveigh Vaginal Repair Balloon Catheter is equivalent to the predicate EpiStat/V-Stat Vaqinal Tamponade Balloon with respect to intended use and technological characteristics.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Glenveigh Surgical, LLC c/o Ms. Penny Northcutt, RAC, COA Regulatory Consultant for Glenveigh Surgical REGSolutions, LLC 717 Lakeglen Drive SUWANEE GA 30034
APR 1 4 2010
K093904 Trade Name: Glenveigh Vaginal Repair Balloon Catheter Regulation Number: 21-CFR & 884,4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: KNA Dated: March 30, 2010 Received: March 31, 2010
Dear Ms. Northcutt:
Re:
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. 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
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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/ReportaProblem/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,
Janine M. Morris
Acting Director. Division of Reproductive. Abdominal, and Radiological Devices office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K093904 510(k) Number (if known):
Device Name: GLENVEIGH VAGINAL REPAIR BALLOON CATHETER
Indications For Use:
The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure.
Prescription Use × (Part 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)
Hulen Rumen
(Division Sidn-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.