(64 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven components. There are no mentions of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
No
The device is used to establish pneumoperitoneum for gynecologic laparoscopic procedures, which is a preparatory step for surgery, not a therapeutic intervention itself. It facilitates a procedure but doesn't treat a disease or condition directly.
No
The device facilitates a surgical procedure (laparoscopy) by establishing pneumoperitoneum. It does not gather information about a patient's health status or diagnose a condition.
No
The device description clearly states it is a physical, single-use device made of polycarbonate housing with a port and stopcock, indicating it is a hardware device.
Based on the provided information, the VereSure Bell is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use in the peri-umbilical region of the abdominal wall during gynecologic laparoscopic procedures. This describes a surgical device used on the patient's body, not a device used to test samples outside the body.
- Device Description: The description details a physical device with a housing, port, and stopcock for use in a surgical setting. It doesn't mention any components for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is to facilitate pneumoperitoneum, which is a physical manipulation of the body cavity.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VereSure Bell does not fit this description.
N/A
Intended Use / Indications for Use
The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
HIF
Device Description
The VereSure Bell is a single-use device used during gynecologic laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate housing containing a sealable port for introduction of standard Veress needles and a stopcock for attachment to a sterile standard hospital vacuum line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peri-umbilical region of the abdominal wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Results of animal and clinical testing demonstrate that the VereSure Bell is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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
JUL 2 1 2006
510(K) SUMMARY
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Date Prepared: July 15, 2006
510(k) number: _______________________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________
Applicant Information:
VereSure Inc. 900 Welch Road Palo Alto, CA 94304
Contact Person
Robert Chin. Ph.D. Phone Number: (650) 593-5225 rjchin@pacbell.net E-mail: and the comments of the country
Device Information:
| Trade Name: | VereSure Bell |
|---|---|
| Classification: | Class II |
| Classification Name: | Laparoscopic Insufflator and Accessories |
Physical Description:
The VereSure Bell is a single-use device used during gynecologic laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate housing containing a sealable port for introduction of standard Veress needles and a stopcock for attachment to a sterile standard hospital vacuum line.
Intended Use:
The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.
Equivalent Device:
The subject device is substantially equivalent in intended use and/or method of operation to the Taut insufflation Needle (K003703), the EndoPath Ultra Veress Needle (K983925), and the Allis Tissue Forceps (K852726).
Test Results:
Results of animal and clinical testing demonstrate that the VereSure Bell is safe and effective for its intended use.
Summarv:
Based on the intended use, product, performance and clinical information provided in this notification the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.
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Image /page/1/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.
JUL 2 1 2006
VereSure, Inc. % Robert J. Chin, Ph.D. Regulatory Consultant 25 Hartford Avenue SAN CARLOS CA 94070
Re: K061387
Trade/Device Name: VereSure Bell Regulation Number: 21 CFR 884.1730 Regulation Name: Laproscopic insufflator Regulatory Class: II Product Code: HIF Dated: May 12, 2006 Received: May 18. 2006
Dear Dr. Chin:
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/1/Picture/9 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-2006" are printed in a smaller font size. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The entire logo is surrounded by a dotted circle.
noting Public Gr
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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 $10/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 Cbrogdon
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: VereSure Bell
Indications for Use:
The VereSure Bell is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of pneumoperitoneum during gynecologic laparoscopic procedures.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Szymanski
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 1061387
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