(52 days)
Not Found
No
The 510(k) summary describes a physical medical device (a catheter) and its placement method using an endoscope. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on the physical properties and function of the catheter.
Yes
The device is designed for use in the treatment of hydrocephalus, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is described as a ventricular catheter designed for shunting cerebrospinal fluid to treat hydrocephalus, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details physical components made of silicone tubing, including catheters of specific dimensions and a right angle adapter. It also mentions a treatment process for impregnating the tubing with antibiotics. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is a surgical implant designed to drain cerebrospinal fluid (CSF) from the brain's ventricles to treat hydrocephalus. It is a physical device used within the body for a therapeutic purpose.
- Lack of Specimen Analysis: The description does not mention any analysis of bodily fluids or tissues performed by the device itself. Its function is mechanical drainage.
Therefore, based on the provided information, this device falls under the category of a surgical implant or therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The BACTISEAL Endoscopic Ventricular Catheter is designed to be placed with an endoscope, which functions as the stylet. The endoscope will enable visualization of catheter placement. The tip of the catheter has been slit to allow passage of the endoscope through the catheter tip.
The BACTISEAL ventricular and peritoneal catheters are made of radiopaque (bariumimpregnated) silicone tubing and are subjected to a treatment process by which the tubing is impregnated with rifampin and clindamycin hydrochloride.
The ventricular catheter has an inner diameter of 1.4 mm and an outer diameter of 2.7 mm. The catheter is 14 cm in length and is supplied with 24 inlet holes (3 rows of 8 holes) at the proximal end. Depth marks have been added to the catheter (one dot at 5 cm and two dots at 10 cm). A right angle adapter is included.
A 120 cm peritoneal catheter is included in the Bactiseal Endoscopic Ventricular Kit along with the ventricular catheter described above. The peritoneal catheter has an inner diameter of 1.0 mm and an outer diameter of 2.2 mm. The catheter can be trimmed to length as needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain
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)
Bench testing demonstrated that the slit design allows passage of an endoscope through the slit. The device performs according to its description and intended use and supports the safety and effectiveness of the device. The Bactiseal Endoscopic Ventricualar Catheter conforms to its design specifications and is substantially equivalent to the commercially distributed devices for the same 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
§ 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
W11075
510(k) Summary
MAY - 9 2011
| A. Submitter Information | |
|---|---|
| Submitter's name: | Codman & Shurtleff, Inc. |
| Address: | 325 Paramount Drive |
| Raynham, MA 02767 | |
| Telephone: | 508-880-8349 |
| Fax: | 508-977-6428 |
| Contact Person: | Sharon McDermott |
| Date of Submission: | March 17, 2011 |
| B. Trade/Device Name: | CODMAN ® BACTISEAL® Endoscopic Ventricular Catheter |
| CODMAN ® BACTISEAL® Endoscopic Ventricular Catheter Kit | |
| Common Name: | Hydrocephalus catheters |
| Classification Name: | Shunt, Central Nervous System and Components |
| Regulatory Class: | Class II per 21 CFR § 882.5550 |
| Product Code: | JXG |
| C. Predicate Device: | Codman® Neuroguide Endoscopic Placement Catheter (K934196) |
| Codman® Bactiseal ® Catheters (K003322) |
The BACTISEAL Endoscopic Ventricular Catheter is designed D. Device Description: to be placed with an endoscope, which functions as the stylet. The endoscope will enable visualization of catheter placement. The tip of the catheter has been slit to allow passage of the endoscope through the catheter tip.
The BACTISEAL ventricular and peritoneal catheters are made of radiopaque (bariumimpregnated) silicone tubing and are subjected to a treatment process by which the tubing is impregnated with rifampin and clindamycin hydrochloride.
The ventricular catheter has an inner diameter of 1.4 mm and an outer diameter of 2.7 mm. The catheter is 14 cm in length and is supplied with 24 inlet holes (3 rows of 8 holes) at the proximal end. Depth marks have been added to the catheter (one dot at 5 cm and two dots at 10 cm). A right angle adapter is included.
A 120 cm peritoneal catheter is included in the Bactiseal Endoscopic Ventricular Kit along with the ventricular catheter described above. The peritoneal catheter has an inner diameter of 1.0 mm and an outer diameter of 2.2 mm. The catheter can be trimmed to length as needed.
1
CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is E. Intended Use: designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.
F. Summary of technological characteristics of the proposed to the predicate device.
The technological characteristics of the proposed devices are the exact same as the Codman® Bactiseal® Catheters predicate device. The design modification adds a slit to this device which is the same as the ventricular catheter in the predicate Codman® Neuroguide Endoscopic Placement Catheter. CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is substantially equivalent to the predicate devices based on intended use, performance characteristics, materials, and principles of operation.
G. Performance Data
ﺔ--
Bench testingdemonstrated that the slit design allows passage of an endoscope through the slit. The device performs according to its description and intended use and supports the safety and effectiveness of the device. The Bactiseal Endoscopic Ventricualar Catheter conforms to its design specifications and is substantially equivalent to the commercially distributed devices for the same intended use.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head turned to the side.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Codman & Shurtleff, Inc .. C/O Sharon McDermott Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham MA 02767-0350
- 9 2011 MAY
Re: K110751
Trade/Device Name: Codman® Bactiseal Endoscopic Ventricular Catheter Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: Class II Product Code: JXG Dated: March 17, 2011 Received: March 18, 2011
Dear Ms. McDermott:
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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Eatheron for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Codman® BACTISEAL® Endoscopic Ventricular Catheter Device Name:
Indications For Use:
CODMAN® BACTISEAL® Endoscopic Ventricular Catheter is designed for use in the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110751