(90 days)
Not Found
No
The description focuses on the physical components and function of a water-perfused manometry catheter, with no mention of AI or ML for data analysis or interpretation.
No
The device is described as an Esophageal Manometric Catheter intended for "water-perfused manometry of the GI tract," which is a diagnostic procedure to measure pressure, not to treat a condition.
Yes
The device is intended for "water-perfused manometry of the GI tract" and "rectal and anal canal," which involves measuring pressure to assess the function of these anatomical sites, indicating a diagnostic purpose.
No
The device description clearly outlines physical components like PVC tubes, capillary tubes, pressure transducers, and a silicone balloon, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these catheters are used for water-perfused manometry. This is a technique that measures pressure within the GI tract or rectal/anal canal in vivo (within the living body). It involves inserting the catheter and measuring pressure directly, not analyzing a sample taken from the body.
- Intended Use: The intended use is to perform manometry of the GI tract and rectal/anal canal, which is a physiological measurement, not a diagnostic test performed on a sample.
Therefore, the Medtronic Single Use Esophageal Manometric Catheter and Anorectal Manometric Catheter are medical devices used for physiological measurement in vivo, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract. The Medtronic Single Use Anorectal Manometric Catheter is intended for water-perfused manometry of the rectal and anal canal.
Product codes (comma separated list FDA assigned to the subject device)
78 KLA
Device Description
The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract. The Medtronic Single Use Anorectal Manometric Catheter are intended for water-perfused manometry of the rectal and anal tract.
These catheters consist of a multi-lumen PVC tube connected to multiple PVC capillary tubes. The capillary tubes connect to pressure transducers of an infusion system that perfuses each lumen of the catheter with water. Pressure measurements are made at side holes in the multi-lumen PVC tube along the gastro-intestinal tract. A silicone balloon is attached to the end of the catheter body of the anorectal model.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract, rectal and anal canal
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)
In-vitro testing was performed to support substantial equivalence to the predicate devices. The results of this testing indicate that the Medtronic Single Use Esophageal Manometric Catheter and Medtronic Single Use Anorectal Manometric Catheter meet all of the design and performance requirements.
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.
Zinetics EMC Esophageal Manometric Catheter (K884527), Zinetics Anorectal Manometric Catheter (K921682), Mediplus Esophageal Manometry Catheter (K013704), Latitude Esophageal Pressure Catheter and Latitude Ano-Rectal Pressure Catheter (K022023)
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
§ 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).
0
OCT - 9 2003
KO32138 PAGE 1 OF 2
510(K) SUMMARY 10
| Applicant: | Medtronic Gastroenterology and Urology
4000 Lexington Ave N
Shoreview, MN 55126 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Julie Goode
Senior Regulatory Affairs Specialist
Medtronic Gastroenterology and Urology
4000 Lexington Ave N
Shoreview, MN 55126
(763) 514-9670
(763) 514-9703 |
| Trade Name: | Medtronic Single Use Esophageal Manometric Catheter and
Medtronic Single Use Anorectal Manometric Catheter |
| Common Name: | Esophageal Manometry Catheter |
| Classification Name: | Monitor, Esophageal Motility, and Tube
21 CFR 876.1725 |
| Name of Predicate Device | Zinetics EMC Esophageal Manometric Catheter (K884527)
Zinetics Anorectal Manometric Catheter (K921682)
Mediplus Esophageal Manometry Catheter (K013704)
Latitude Esophageal Pressure Catheter and Latitude Ano-
Rectal Pressure Catheter (K022023) |
Device Description
The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract. The Medtronic Single Use Anorectal Manometric Catheter are intended for water-perfused manometry of the rectal and anal tract.
These catheters consist of a multi-lumen PVC tube connected to multiple PVC capillary tubes. The capillary tubes connect to pressure transducers of an infusion system that perfuses each lumen of the catheter with water. Pressure measurements are made at side holes in the multi-lumen PVC tube along the gastro-intestinal tract. A silicone balloon is attached to the end of the catheter body of the anorectal model.
Image /page/0/Picture/7 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. To the left of the word is a circular graphic with a human figure inside. Below the logo, the word "Confidential" is written in a smaller, non-bold font.
510(k) Premarket Notification Medtronic Single-Use Manometric Catheter July 10, 2003
1
KO32138 2 OF 2 PAGE
Performance Standards
No applicable mandatory performance standards or special controls exist for this device.
Statement of Intended Use
The Medtronic Single Use Esophageal Manometric Catheter is intended for waterperfused manometry of the GI tract.
The Medtronic Single Use Anorectal Manometric Catheter is intended for water-perfused manometry of the rectal and anal canal.
Substantial Equivalence
This premarket notification is being submitted for the Medtronic Single Use Esophageal Manometric Catheter and Medtronic Single Use Anorectal Manometric Catheter. Other manometry catheters, previously cleared by FDA, and currently marketed include:
- Zinetics EMC Esophageal Manometric Catheter (K884527, February 28, 1989)
- Zinetics Anorectal Manometry Catheter (K921682, December 29, 1994)
- Mediplus Esophageal Manometry Catheter (K013704, August 5, 2002)
- Latitude Esophageal Pressure Catheter and Latitude Ano-Rectal Pressure . Catheter (K022023, January 7, 2003)
Summary of Testing
The materials used in the Medtronic Single Use Esophageal Manometric Catheter and in the Medtronic Single Use Anorectal Manometric Catheter have been tested for biocompatibility and meets the requirements of ISO 10993-1.
In-vitro testing was performed to support substantial equivalence to the predicate devices. The results of this testing indicate that the Medtronic Single Use Esophageal Manometric Catheter and Medtronic Single Use Anorectal Manometric Catheter meet all of the design and performance requirements.
Conclusion
Through the data and information presented, as well as similarities to a legally marketed device, Medtronic, Inc. considers the Medtronic Single Use Esophageal Manometric Catheter and the Medtronic Single Use Anorectal Manometric Catheter to be substantially equivalent to the previously discussed legally marketed predicate devices.
Image /page/1/Picture/17 description: The image shows the Medtronic logo with the word "Confidential" underneath. The Medtronic logo consists of a stylized human figure inside a circle to the left of the word "Medtronic" in bold, sans-serif font. The word "Confidential" is in a smaller, sans-serif font and is located below the logo.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.
OCT - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Deborah Kidder Regulatory Affairs Specialist Medtronic Gastroenterology and Urology 4000 Lexington Avenue North SHOREVIEW MN 55126-2983
Re: K032138 - -
Trade/Device Name: Medtronic Single Use Esophageal and Anorectal Manometric Catheters; Models 9012P1201, -11, -21, -31, -41, -51, -61, and -71; 9012P1301. -11. -21. -31. and -41 Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: 78 KLA Dated: July 10, 2003
Received: July 11, 2003
Dear Ms. Kidder:
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. Drue, 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 (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); 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.
3
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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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/dsma/dsmamain.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:
Medtronic Single Use Esophageal Manometric Catheter Device Name: Medtronic Single Use Anorectal Manometric Catheter
032138
Indications for use:
The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract
The Medtronic Single Use Anorectal Manometric Catheter is intended for water-perfused manometry of the rectal and anal canal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter-Use
Nancy C Brogdon
0
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
Snber, K032138