(136 days)
Preamendment - CODMAN® HOLTER® In-Line Shunt Filter, Preamendment - CODMAN® HOLTER® Cerebral Catheter- Reservoir, LeRoy Design, Preamendment – CODMAN® ACCU-FLO® Straight Connectors
No
The summary describes mechanical components (connectors, reservoirs, filter) for hydrocephalus shunt systems and focuses on material properties and MRI compatibility. There is no mention of AI, ML, image processing, or data analysis capabilities.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that various components (e.g., Codman-Medos Connector, Cerebral Catheter-Reservoir) are "for use in the treatment of hydrocephalus" or "for the purpose of diagnostic studies or therapeutic drug administration," indicating a direct therapeutic purpose.
Yes
The Ventriculostomy Reservoir Set and the Cerebral Catheter-Reservoir are indicated for use "for the purpose of diagnostic studies". The device description also states that "The reservoirs are made of silicone, stainless steel, and/or plastic and are used for the purpose of diagnostic studies or therapeutic drug administration." which confirms the diagnostic purpose.
No
The device description explicitly states that the hydrocephalus accessories consist of physical components made of stainless steel, plastic, and silicone, such as connectors, reservoirs, and a filter. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as components of hydrocephalus shunt systems used for draining or shunting cerebrospinal fluid (CSF), gaining access to cerebral ventricles for diagnostic studies or therapeutic drug administration, and filtering particles within the shunt system. These are all surgical and therapeutic procedures performed in vivo (within the body).
- Device Description: The device description details connectors, reservoirs, and a filter made of materials like stainless steel, plastic, and silicone. These are physical components designed for implantation or connection within a surgical system.
- Lack of IVD Characteristics: An IVD device is specifically intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided text does not mention any such use or interaction with bodily specimens outside the body.
The device is clearly intended for surgical implantation and use within the human body as part of a hydrocephalus shunt system.
N/A
Intended Use / Indications for Use
The hydrocephalus accessories are intended for use with Codman's Hydrocephalus Shunt Systems.
The Codman-Medos Connector is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 rite Type P. Pixation and coming with nonabsorbable sutures in a surgical application.
The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of 0.8 me rype b fixation and obling to 1.2 mm nominal I.D. silicone rubber tubing, and min fromman f.D. Billions fulls of the version in a surgical applical application.
The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device. When used with the shunting device, the ventriculostomy reservoir is also indicated for use as the proximal fluid pathway.
The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to The ACCO-FLO Three Way Ochniction our be unities into the right atium of the heart or the shunt cereorospinal had from the lateral vonthologime and fixation of approximately 1.3 mm peritoneal cavity, providing they are used in the joining aurrical application pentioneal cavily, providing they are about in the John's and surgical application.
The ACCU-FLO Connectors can be utilized as a component in systems designed to shunt The AOOO+ LO Ochhoolors our be anticles into the right atrium of the heart or the peritoneal cerebrospiral not from the joining and fixation of approximately 1.3 mm nominal I.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.
The Cerebral Catheter-Reservoir is indicated for use as a component of a shunting system to The Gerebral Vatheter-1000Non in Indication for see and cavities for the purpose of diagnostic studies, therapeutic drug administration, or the diversion of fluid.
The In-Line Shunt Filter is indicated for use to filter particles that are larger than approximately The in Line Gham Mis suspected and when shunting is the procedure of choice in the treatment of hydrocephalus.
Product codes (comma separated list FDA assigned to the subject device)
JXG
Device Description
The hydrocephalus accessories consist of connectors, reservoirs, and a filter. The connectors are made of stainless steel or plastic and are used in the joining and fixation of silicone rubber tubing. The reservoirs are made of silicone, stainless steel, and/or plastic and are used for the purpose of diagnostic studies or therapeutic drug administration. The filter is made of stainless steel and silicone and is used to filter particles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Central nervous system, cerebral ventricles or other intracranial cavities, right atrium of the heart, 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)
Bench testing was performed according to the following MRI standards: ASTM F 2052, ASTM F 2213, ASTM F 2119, and ASTM F 2182. The test results demonstrate that there is no added risk to the patient when exposed to a 3 Tesla MR system. The devices that are made of silicone and plastic were evaluated and determined to be MR Safe since they do not contain metallic or conducting materials. The results and evaluation conclude that the devices are MR Conditional or MR Safe in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503 and are substantially equivalent to the predicate devices.
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.
Preamendment - CODMAN® HOLTER® In-Line Shunt Filter, Preamendment - CODMAN® HOLTER® Cerebral Catheter- Reservoir, LeRoy Design, Preamendment – CODMAN® ACCU-FLO® Straight Connectors
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.
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).
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510(k) SUMMARY
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FEB 18 2011
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| Company Name: | Codman & Shurtleff, Inc. |
|---|---|
| Company Address: | 325 Paramount Drive |
| Raynham, MA 02767-0350 | |
| Phone: | (508) 828-3421 |
| Fax: | (508) 828-2777 |
| Contact Person: | Jocelyn Raposo, Senior Regulatory Affairs Specialist |
| Date: | October 4, 2010 |
| Name of the Device: | Central Nervous System Fluid Shunt and Components |
| Propriety / Trade Name: | CODMAN® HOLTER® In-Line Shunt Filter, Hoffman Design |
| CODMAN® HOLTER® Cerebral Catheter-Reservoir, LeRov Design | |
| CODMAN® ACCU-FLO® Straight Connector, Stainless Steel | |
| CODMAN® MEDOS® Straight Connector | |
| CODMAN® HOLTER® Type A Fixation and Joining Connector | |
| CODMAN® HOLTER® Type B Fixation and Joining Connector | |
| CODMAN® ACCU-FLO® Connector, Three Way, Stainless Steel | |
| CODMAN® HOLTER® RICKHAM® Reservoir | |
| CODMAN® HOLTER® SALMON™-RICKHAM® Reservoir | |
| CODMAN® ACCU-FLO® Right Angle Connector, Stainless Steel | |
| CODMAN® MEDOS® Right Angle Connector | |
| CODMAN® HOLTER® SELKER Reservoir | |
| CODMAN® ACCU-FLO® Straight Connector, Plastic | |
| CODMAN® ACCU-FLO® Connector, Three Way, Plastic | |
| CODMAN® ACCU-FLO® Right Angle Connector, Plastic | |
| Common Name: | Hydrocephalus Shunt System Accessories |
| Classification: | Class II (JXG) per 21 CFR § 882.5550 |
| Central Nervous System Fluid Shunt and Components | |
| Legally Marketed Device: | Preamendment - CODMAN® HOLTER® In-Line Shunt Filter, |
| Hoffman Design | |
| Preamendment - CODMAN® HOLTER® Cerebral Catheter- | |
| Reservoir, LeRoy Design | |
| Preamendment – CODMAN® ACCU-FLO® Straight Connectors |
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| K944222 | - CODMAN® MEDOS® Straight Connector |
|---|---|
| Preamendment | - CODMAN® HOLTER® Type A Fixation and Joining Connector |
| Preamendment | - CODMAN® HOLTER® Type B Fixation and Joining Connector |
| Preamendment | - CODMAN® ACCU-FLO® Connector, Three Way |
| Preamendment | - CODMAN® HOLTER® RICKHAM® Reservoir |
| Preamendment | - CODMAN® HOLTER® SALMON™-RICKHAM® Reservoir |
| Preamendment | - CODMAN® ACCU-FLO® Right Angle Connectors |
| K944222 | - CODMAN® MEDOS® Right Angle Connector |
| Preamendment | - CODMAN® HOLTER® SELKER Reservoir |
| K973774 | - CODMAN® ACCU-FLO® Straight Connector, Plastic |
| K973774 | - CODMAN® ACCU-FLO® Connector, Three Way, Plastic |
| K973774 | - CODMAN® ACCU-FLO® Right Angle Connector, Plastic |
| Device Description: | The hydrocephalus accessories consist of connectors, reservoirs, and a filter. The connectors are made of stainless steel or plastic and are used in the joining and fixation of silicone rubber tubing. The reservoirs are made of silicone, stainless steel, and/or plastic and are used for the purpose of diagnostic studies or therapeutic drug administration. The filter is made of stainless steel and silicone and is used to filter particles. |
| Intended Use: | The hydrocephalus accessories are intended for use with Codman's Hydrocephalus Shunt Systems. |
| Summary of technological characteristics of the proposed to the predicate device: | |
| No new technological characteristics are being introduced in comparison to the predicate devices. The technological characteristics of the devices remain the same. No changes are being made to the device design, materials, performance, or intended use. | |
| Performance Data: | Bench testing was performed according to the following MRI standards: ASTM F 2052, ASTM F 2213, ASTM F 2119, and ASTM F 2182. The test results demonstrate that there is no added risk to the patient when exposed to a 3 Tesla MR system. The devices that are |
made of silicone and plastic were evaluated and determined to be MR Safe since they do not contain metallic or conducting materials. The
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K102961
results and evaluation conclude that the devices are MR Conditional or MR Safe in 3-Tesla Magnetic Resonance Imaging (MRI) systems according to ASTM F 2503 and are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of an eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Codman & Shurtleff. Inc. c/o Ms. Jocelyn Raposo Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767-0350
FEB 1 8 2011
Re: K102961
Trade/Device Name: CODMAN® HOLTER® In-Line Shunt Filter, Hoffman Design CODMAN® HOLTER® Cerebral Catheter-Reservoir, LeRoy Design CODMAN® ACCU-FLO® Straight Connector, Stainless Steel CODMAN® MEDOS® Straight Connector CODMAN® HOLTER® Type A Fixation and Joining Connector CODMAN® HOLTER® Type B Fixation and Joining Connector CODMAN® ACCU-FLO® Connector, Three Way, Stainless Steel CODMAN® HOLTER® RICKHAM® Reservoir CODMAN® HOLTER® SALMON™-RICKMAN® Reservoir CODMAN® ACCU-FLO® Right Angle Connector, Stainless Steel CODMAN® MEDOS® Right Angle Connector CODMAN® HOLTER® SELKER Reservoir CODMAN® ACCU-FLO® Straight Connector, Plastic CODMAN® ACCU-FLO® Connector, Three Way, Plastic CODMAN® ACCU-FLO® Right Angle Connector, Plastic
Regulation Number: 21 CFR 882.5550 Regulation Name: Central nervous system fluid shunt and components Regulatory Class: II Product Code: JXG Dated: January 18, 2011 Received: January 19, 2011
Dear Ms. Raposo:
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
4
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.
- 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 of medical device-related adverse events) (21 CFR 803); 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.
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,
Tesia Alexander
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
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માળટવદા 510(k) Number (if known): __
Device Name:
CODMAN® MEDOS® Straight Connector CODMAN® MEDOS® Right Angle Connector
Indications for Use:
The Codman-Medos Connector is for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
K102961 510(k) Number
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1102961 510(k) Number (if known):
Device Name:
CODMAN® HOLTER® Type A Fixation and Joining Connector
Indications for Use:
The Type A Fixation and Joining Connector is indicated for use in the joining and fixation of 1.2 rite Type P. Pixation and coming with nonabsorbable sutures in a surgical application.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102961
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K102961 510(k) Number (if known): _
Device Name:
CODMAN® HOLTER® Type B Fixation and Joining Connector
Indications for Use:
The Type B Fixation and Joining Connector is indicated for use in the joining and fixation of 0.8 me rype b fixation and obling to 1.2 mm nominal I.D. silicone rubber tubing, and min fromman f.D. Billions fulls of the version in a surgical applical application.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
4102961 ^^^^ (^imber
8
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
CODMAN® HOLTER® SEL.KER Reservoir CODMAN® HOLTER® RICKHAM® Reservoir CODMAN® HOLTER® SAL.MON™-RICKHAM® Reservoir
Indications for Use:
The Ventriculostomy Reservoir Set is indicated for use to gain access to the cerebral ventricles or other intracranial cavities for the purpose of diagnostic studies or therapeutic drug administration with or without a shunting device. When used with the shunting device, the ventriculostomy reservoir is also indicated for use as the proximal fluid pathway.
· Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
4102a61 510(k) Number_
9
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
CODMAN® ACCU-FLO® Connector, Three Way (Stainless Steel and Plastic)
Indications for Use:
The ACCU-FLO Three Way Connector can be utilized as a component in systems designed to The ACCO-FLO Three Way Ochniction our be unities into the right atium of the heart or the shunt cereorospinal had from the lateral vonthologime and fixation of approximately 1.3 mm
peritoneal cavity, providing they are used in the joining aurrical application pentioneal cavily, providing they are about in the John's and surgical application.
Prescription Use
(Part 21 CFR 801 Subpart D) X
AND/OR
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102961
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ત્વજવદા 510(k) Number (if known): __
Device Name:
CODMAN® ACCU-FLO® Straight Connectors (Stainless Steel and Plastic) OODMAN® ACCU-FLO® Right Angle Connectors (Stainless Steel and Plastic)
Indications for Use:
The ACCU-FLO Connectors can be utilized as a component in systems designed to shunt The AOOO+ LO Ochhoolors our be anticles into the right atrium of the heart or the peritoneal cerebrospiral not from the joining and fixation of approximately 1.3 mm nominal I.D. silicone rubber tubing with nonabsorbable sutures in a surgical application.
× ´ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KID2961 510(k) Number_
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મા૦ટવદા 510(k) Number (if known): _
Device Name:
CODMAN® HOLTER® Cerebral Catheter Reservoir, Leroy Design
Indications for Use:
The Cerebral Catheter-Reservoir is indicated for use as a component of a shunting system to The Gerebral Vatheter-1000Non in Indication for see and cavities for the purpose of diagnostic studies, therapeutic drug administration, or the diversion of fluid.
Prescription Use
X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
Joe HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KIDZACI 510(k) Number.
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
CODMAN® HOLTER® In-Line Shunt Filter, Hoffman Design
Indications for Use:
The In-Line Shunt Filter is indicated for use to filter particles that are larger than approximately The in Line Gham Mis suspected and when shunting is the procedure of choice in the treatment of hydrocephalus.
Prescription Use
(Part 21 CFR 801 Subpart D) X
AND/OR
Over-The-Counter Use _ (Part 21 CFR 801 Subpart C)
JOE HUTTER
ision Sign-Off) · of Ophthalmic, Neurological and Ear, "Froat Devices
K102961 STUCK , Nomber __