(35 days)
Not Found
Not Found
No
The summary describes a physical catheter with antimicrobial properties, and there is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is intended for use in the treatment of hydrocephalus as a component of a shunt system, which aims to alleviate a medical condition.
No
Explanation: The device description states its use is for "treatment of hydrocephalus as a component of a shunt system." There is no mention of diagnosing conditions.
No
The device description clearly states it is a physical catheter made from silicone and impregnated with antibiotics, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of hydrocephalus by draining or shunting cerebrospinal fluid (CSF). This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a catheter designed to be implanted in the body. It is made of silicone and impregnated with antibiotics.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is clearly designed for direct use within the patient's body for treatment, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
Codman BACTISEAL™ Barium Striped Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Product codes (comma separated list FDA assigned to the subject device)
JXG, HCA
Device Description
Codman BACTISEAL™ Barium Striped Catheters are manufactured from barium striped silicone which is impregnated with Clindamycin Hydrochloride and Rifampicin. BACTISEAL™ catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Substantial equivalence for this device was based upon performance testing and in vitro testing. All test results demonstrated the substantial equivalence of the product to 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.
Codman BACTISEAL™ Catheters, Uni-Shunt Catheters with Elliptical Reservoir, CODMAN HAKIM™ Shunt Systems
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
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).
0
MAY 1 4 2003
EXHIBIT A
KO3/123
510(k) Summary Codman BACTISEAL™ Barium Striped Catheters
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Contact Person
Elizabeth Dolan Regulatory Affairs Specialist Telephone Number: (508) 828-3262 Fax Number: (508) 828-3212
Name of Device
| Proprietary Name: | Codman BACTISEAL™ Barium Striped Catheters |
|---|---|
| Common Name: | Hydrocephalus catheters |
| Classification Name: | Central Nervous System Fluid Shunt and Components |
Device Classification
Class II per 21 CFR & 882.5550 - Central nervous system fluid shunt and components (84 JXG)
Statement of Substantial Equivalence
Codman BACTISEAL™ Barium Striped Catheters are substantially equivalent to Codman BACTISEAL™ Catheters, Uni-Shunt Catheters with Elliptical Reservoir. CODMAN HAKIM™ Shunt Systems based on the subject device's similarity to the predicate devices in intended use, materials, design, and dimensions.
Indications for Use
Codman BACTISEAL™ Barium Striped Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
1
Physical Description
Codman BACTISEAL™ Barium Striped Catheters are manufactured from barium striped silicone which is impregnated with Clindamycin Hydrochloride and Rifampicin. BACTISEAL™ catheters have been shown in laboratory studies to reduce the colonization of gram positive bacteria on the tubing surface.
Device Testing
Substantial equivalence for this device was based upon performance testing and in vitro testing. All test results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.
2
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 image of three human figures, represented by simple lines, facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2003
Ms. Elizabeth Dolan Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K031123
Trade/Device Name: Codman BACTISEAL™ Barium Striped Catheters Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular catheter Regulatory Class: II Product Code: HCA Dated: April 7, 2003 Received: April 14, 2003
Dear Ms. Dolan:
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 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.
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Page 2 - Ms. Elizabeth Dolan
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 (301) 594-4659. 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,
Muriam C. Provost
(d Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
K 031123
Device Name:
Codman BACTISEAL™ Barium Striped Catheters
Indications For Use:
Codman BACTISEAL™ Barium Striped Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR §801.109)
OR
Over-the-Counter Use
iriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031123