(84 days)
Not Found
No
The device description focuses on the physical materials and design of a catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is described as a component of a cerebrospinal fluid shunt system, which is used to redirect fluid to treat conditions like hydrocephalus. This active intervention in the body's physiological processes for treatment demonstrates a therapeutic purpose.
No
The device is a component of a cerebrospinal fluid shunt system intended for shunting CSF into the peritoneal cavity, which is a therapeutic rather than diagnostic function. It does not mention any role in detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is fabricated from physical materials (silicone elastomer tubing, barium-impregnated core) and includes a physical fixation tab. It is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Small Lumen Peritoneal Catheter is a surgical implant designed to drain cerebrospinal fluid from the brain into the peritoneal cavity. It is a physical device used within the body for fluid management, not for analyzing samples outside the body.
- Intended Use: The intended use clearly states "shunting cerebrospinal fluid into the peritoneal cavity," which is a surgical procedure, not an in vitro diagnostic test.
Therefore, based on the provided information, this device falls under the category of a surgical implant or medical device used for fluid drainage, not an IVD.
N/A
Intended Use / Indications for Use
The Small Lumen Peritoneal Catheter is the distal component of a cerebrospinal fluid shunt system for use in shunting cerebrospinal fluid into the peritoneal cavity.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The Small Lumen Peritoneal Catheter is fabricated from radiopaque silicone elastomer tubing with a barium-impregnated core encapsulated in a clear silicone outer sheath. An enlarged end allows connection to Medtronic Neurosurgery's PS Medical cerebrospinal fluid shunting valves. The distal segment of the catheter contains no wall slits and the tip is open ended. A silicone elastomer fixation tab is included. It is designed to secure the catheter to surrounding fascia. This catheter is not indicated for placement into the right atrium of the heart.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
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)
Not Found
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
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).
0
073/39
4. 510(k) Summary
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.
| Establishment Registration Number: | 2021898 | JAN 30 |
|---|---|---|
| Address of Manufacturer: | Medtronic Neurosurgery | |
| 125 Cremona Drive | ||
| Goleta CA, 93117 | ||
| (805) 968-1546 ext. 1773 | ||
| Fax: (805) 968-9336 | ||
| Contact Person: | Jeffrey Henderson | |
| Date: | November 5, 2007 | |
| Trade or Proprietary Name: | Small Lumen Peritoneal Catheter | |
| Common usual or Classification Name: | Central nervous system fluid shunt and | |
| components (882.5550) | ||
| Predicate Device Identification: | CSF-Cardiac/Peritoneal Catheter |
Description: The Small Lumen Peritoneal Catheter is fabricated from radiopaque silicone elastomer tubing with a barium-impregnated core encapsulated in a clear silicone outer sheath. An enlarged end allows connection to Medtronic Neurosurgery's PS Medical cerebrospinal fluid shunting valves. The distal segment of the catheter contains no wall slits and the tip is open ended. A silicone elastomer fixation tab is included. It is designed to secure the catheter to surrounding fascia. This catheter is not indicated for placement into the right atrium of the heart.
(K792005)
Intended Use: The Small Lumen Peritoneal Catheter is the distal component of a cerebrospinal fluid shunt system for use in shunting cerebrospinal fluid into the peritoneal cavity.
Intended Use of predicate device(s): The CSF-Cardiac/Peritoneal Catheter is the distal component of a cerebrospinal fluid shunt system for use in shunting cerebrospinal fluid into the right atrium of the heart or the peritoneal cavity.
Technological Comparison: Medtronic Neurosurgery submits that the materials of fabrication, intended use, and the fundamental scientific technology of the Small Lumen Peritoneal Catheter are the same as the previously reviewed and cleared CSF Cardiac/Peritoneal Catheter. Based upon the summary above,
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Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Small Lumen Peritoneal Catheter compared to the predicate and currently marketed devices.
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2 * ( 9
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three curved lines that resemble a human figure.
Public Health Service
JAN 30 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Neurosurgery % Mr. Jeffrey Henderson Vice President, Quality & Regulatory Affairs 125 Cremona Drive Goleta, California 93117-5500
Re: K073139
Trade/Device Name: Small Lumen Peritoneal Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: January 10, 2008 Received: January 11, 2008
Dear Mr. Henderson:
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 (PMA), 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.
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
3
Page 2 -- Mr. Jeffrey Henderson
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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
II. Statement of Indications for Use
510(k) Number (if known):
Ko 73139
Device Name: Small Lumen Peritoneal Catheter
Indications for Use:
The Small Lumen Peritoneal Catheter is designed as the distal component of a cerebrospinal fluid shunt system for use in shunting cerebrospinal fluid into the peritoneal cavity.
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)
(Division Sig-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 1078135 |
|---|---|
| --------------- | --------- |