(242 days)
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are intended for Manometry analysis of Gastro-Intestinal and Ano-Rectal Tract.
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are indicated for patients where Gastro-Intestinal and Ano-Rectal tracts pressure measurements are required, such as for detection of GI tract disorders. The products are to be used by a trained physician.
The SarMed Single Use Esophageal Manometry and Ano-Rectal Manometry Catheters are available in some different configurations, respect to number of lumen and number of tubes. They are designed to be connected to a manometric infusion pump and allow, by the way of a defined number of holes, the measurement of pressure on the Gastro-Intestinal and Ano-Rectal Tract.
This document is a 510(k) Premarket Notification for SarMed Single Use Esophageal Manometry Catheters and Single Use Ano-Rectal Manometry Catheters. It describes the device, its intended use, indications for use, and a comparison to predicate devices. It does not contain acceptance criteria or a study demonstrating device performance against specific metrics.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document focuses on establishing substantial equivalence to legally marketed predicate devices, rather than presenting de novo performance study results with specific performance metrics.
Specifically, the document states:
- "The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters has been tested for biocompatibility and meets the requirements of ISO 10993-1 schemes, for the intended use of the devices." (Page 1)
- "The catheters in object are technologically equivalent to the predicate devices above listed, both in physical than in design characteristics." (Page 1)
- The FDA letter confirms "substantial equivalence (for the indications for use stated in the enclosure) to legally marketed predicate devices." (Page 2)
This indicates that the submission relies on demonstrating similarity to existing devices and meeting a general biocompatibility standard, not on a new clinical or performance study with defined acceptance criteria and detailed performance metrics.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the word "SarMed" in a bold, black font. The "Sar" portion of the word is in a cursive-like font, while the "Med" portion is in a blocky, sans-serif font. The letters are closely spaced together, creating a unified visual element.
510(K) DOCUMENTATION SECTION 5
Image /page/0/Picture/2 description: The image shows the text "K062362" at the top, with the word "Gruppo" underneath. Below that is the word "MEDICA" and the phrase "PAGE 1 OF 2" to the right. The word "Group" is underlined at the bottom.
Premarket notification [510(K)] Summary APR 1 3 2007 As per 21 CFR. Section 807.92(C)
SarMed srl Località Sa Stoia Applicant 09016 Iglesias Italy Dr. Claudio Rossi QA/RA Manager Contact Ph : 0039 0535 51159 Fax : 0039 0535 52605 quality@medica.it Single Use Esophageal Manometry Catheters and Trade Name Single Use Ano-Rectal Manometry Catheters Common name Esophageal and Ano-Rectal Manometry Catheters Gastrointestinal motility monitoring system Classification name 21 CFR Sec. 876.1725 Product Code KLA Medtronic Single Use Esophageal Manometric Catheter And Medtronic Single Use Ano-Rectal Manometric Catheter (K032138) Predicate Devices Mediplus Single Use Ano-Rectal Manometry Catheter (K031617) Mediplus Esophageal Manometry Catheter (K013704)
Section 5, Page 2 of 3
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the word "SarMed" in a bold, stylized font. The "Sar" portion is in a cursive font, while the "Med" portion is in a blocky, sans-serif font. The entire word is in black, contrasting with the white background.
510(K) DOCUMENTATION SECTION 5
Image /page/1/Picture/2 description: The image shows the text "K062362", "Gruppo MEDICA Group", and "PAGE 2 of 2". The text appears to be part of a document or report. The text "K062362" is underlined.
DEVICE DESCRIPTION
The SarMed Single Use Esophageal Manometry and Ano-Rectal Manometry Catheters are available in some different configurations, respect to number of lumen and number of They are designed to be connected to a manometric infusion pump and allow, by tubes. the way of a defined number of holes, the measurement of pressure on the Gastro-Intestinal and Ano-Rectal Tract.
INTENDED USE
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are intended for Manometry analysis of Gastro-Intestinal and Ano-Rectal Tract.
INDICATIONS FOR USE
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are indicated for patients where Gastro-Intestinal and Ano-Rectal tracts pressure measurements are required, such as for detection of GI tract disorders. The products are to be used by a trained physician.
TECHNOLOGICAL CHARACTERISTICS
The catheters in object are technologically equivalent to the predicate devices above listed, both in physical than in design characteristics. Like all the Predicate Devices listed, the SarMed Ano-Rectal and Esophageal Manometry Catheters are made with Medical Grade plastics that has been used in a wide range of Medical applications :
| Tab 5-1 | MATERIAL OF BODY CONTACT PARTS | |
|---|---|---|
| ESOPHAGEAL | ANO-RECTAL | |
| CANNULA | PVC | PVC |
| TUBES | PVC | PVC |
| BALLOON | NA | LATEX OR LATEXFREE RUBBER |
TESTING AND SAFETY
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters has been tested for biocompatibility and meets the requirements of ISO 10993-1 schemes, for the intended use of the devices.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 3 2007
Dr. Antonio Rossetti OA/RA Manager SarMed s.r.1. Via Degli Artigiani, 6 41036 Medolla ITALY
K062362 Re:
Trade/Device Name: Single Use Esophageal Manometry Catheters and Single Use Ano-Rectal Manometry Catheters Regulation Number: 21 CFR §876.1725
Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: KLA Dated: March 27, 2007 Received: March 30, 2007
Dear Dr. Rossetti:
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/11 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The logo also features three stars at the bottom. The text is arranged around the circle's perimeter, and the FDA acronym is prominently displayed in the center. The logo appears to be a commemorative emblem for the centennial anniversary of the Food and Drug Administration.
Protecting and Promoting Public Health
{3}------------------------------------------------
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known) : K062362
Single Use Esophageal Manometry Catheters and Device Name : Single Use Ano-Rectal Manometry Catheters
Indications for Use :
The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are indicated for patients where Gastro-Intestinal and Ano-Rectal tracts pressure measurements are required, such as for detection of GI tract disorders. The products are to be used by a trained physician.
Prescription Use YES Over-The-Counter Use NO AND/OR (Part 21 CFR 801 Subpart D) (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. Seipmann
ivision Sion-Off of Reproductive, Abdomin
Section 4, Page 2 of 2
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).