(79 days)
Sil-Med Suction Reservoir, Cordis Integral Drainage/Ventricular/Lumbar Drainage Sets
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No
The summary describes a mechanical drainage system with no mention of AI or ML components.
No
The device is described as a suction reservoir kit for fluid drainage, which is a supportive function and not directly therapeutic in itself. It is used to collect fluid, preventing build-up, but doesn't treat a disease or condition.
No
The device is described as a suction reservoir kit for drainage of extraventricular fluid collections, which is a therapeutic function, not a diagnostic one. While it allows for measurement of fluid collections, this is for monitoring the quantity of drained fluid, not for diagnosing a condition.
No
The device description clearly outlines physical components: a Suction Reservoir and extension tubing with a Luer connector. These are hardware components, not software.
Based on the provided information, the Cordis Suction Reservoir Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "drainage of extraventricular fluid collections." This is a procedure performed on the patient's body (in vivo), not on samples taken from the patient's body (in vitro).
- Device Description: The description details a device for collecting and measuring fluid drained from the body. It doesn't mention any components or functions related to testing or analyzing biological samples.
- Lack of IVD Indicators: There are no mentions of analyzing samples, detecting substances, or providing diagnostic information based on laboratory tests, which are hallmarks of IVD devices.
Therefore, the Cordis Suction Reservoir Kit is a medical device used for drainage, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Cordis Suction Reservoir Kit is intended to be used with the Cordis Subdural Drainage Catheter for drainage of extraventricular fluid collections.
Product codes
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Device Description
The kit consists of a Suction Reservoir and an extension tubing with an integrated male Luer connector. The Suction Reservoir has a 100 cc capacity with graduated markers every 25 cc allowing measurement of fluid collections. It also incorporates an anti-reflux valve to prevent backflow. The Suction Reservoir provides consistent negative pressure while returning to its original shape and volume.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Sil-Med Suction Reservoir, Cordis Integral Drainage/Ventricular/Lumbar Drainage Sets
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4680 Nonpowered, single patient, portable suction apparatus.
(a)
Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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1963839
ATTACHMENT - 1
SUMMARY OF SAFETY AND EFFECTIVENESS
Trade (proprietary) Name a.
Cordis Suction Reservoir Kit
DEC 1 2 1996
Common/Classification Name b.
Suction reservoir/Nonpowered, single patient, portable suction apparatus.
Applicant's Name and Address C.
Cordis Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014
Classification d.
This device is classified as Class I (21 CFR 878.4680).
Predicate Devices e.
Sil-Med Suction Reservoir Cordis Integral Drainage/Ventricular/Lumbar Drainage Sets
f. Performance Standards
No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description g.
The Cordis Suction Reservoir Kit is intended to be used with the Cordis Subdural Drainage Catheter for drainage of extraventricular fluid collections. The kit consists of a Suction Reservoir and an extension tubing with an integrated male Luer connector. The Suction Reservoir has a 100 cc capacity with graduated markers every 25 cc allowing measurement of fluid collections. It also incorporates an anti-reflux valve to prevent backflow. The Suction Reservoir provides consistent negative pressure while returning to its original shape and volume.
1
Biocompatibility h.
No new issues of biocompatibility are raised. The Suction Reservoir was cleared for a wide variety of applications in post-operative drainage procedures, including neurosurgery applications. The extension line was cleared for a similar application (cerebrospinal fluid drainage, sampling and collection).
I. Summary of Substantial Equivalence :
The indications and contraindications of the Cordis Suction Reservoir Kit are included in those of the predicates. The design, materials, manufacturing methods and specifications of the Cordis Suction Reservoir Kit are equivalent to those of the predicate devices and do not raise any new issues relating to safety and effectiveness for its intended use.
' Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, ". . . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without premarket approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).