(87 days)
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No
The summary describes a mechanical tunneling device and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The Reigel Tunneling Device is an instrument used to facilitate the placement of shunts; it does not directly treat a disease or condition itself.
No
The device is described as being used for "tunneling and passing shunt components under the skin," which is a surgical or procedural function, not a diagnostic one.
No
The device description explicitly states it is used for "tunneling and passing shunt components under the skin," which describes a physical, sterile device, not software.
Based on the provided information, the Reigel Tunneling Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is used for a surgical procedure (tunneling and passing shunt components under the skin). This is an in-vivo application, meaning it's used directly on or within the living body.
- Device Description: The description focuses on the physical function of the device in a surgical context.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are specifically designed to be used outside the body to analyze biological samples. The Reigel Tunneling Device is a surgical instrument used inside the body.
N/A
Intended Use / Indications for Use
The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen.
Product codes (comma separated list FDA assigned to the subject device)
84GYK
Device Description
The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen. The device is supplied sterile. The materials comprising the device have an established history of use in medical product manufacturing.
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
The head to the abdomen
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 882.4545 Shunt system implantation instrument.
(a)
Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.(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 the limitations in § 882.9.
0
510 (k) Premarket Notification Reigel Tunneling Device
ರಿ
962761
I.510(K) SUMMARY
Submitted By:
April Lavender COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 July 12, 1996
Device:
| Trade Name: | Reigel Tunneling Device |
|---|---|
| Common/Usual Name: | Tunneler, Catheter Passer |
| Proposed Classification: | Shunt System Implantation Instrument |
| 21 CFR 882.4545 (84GYK), Class I |
OCT 11 1996
Predicate Devices:
The Reigel Tunneling Device is similar in terms of intended use, materials of construction, and technoloqical characteristics to predicate devices reviewed as instruments used to place cerebrospinal fluid shunt systems.
Device Description:
The Reigel Tunneling Device is used for tunneling and passing shunt components under the skin for the placement of cerebrospinal fluid shunts from the head to the abdomen. The device is supplied sterile. The materials comprising the device have an established history of use in medical product manufacturing.
Substantial Equivalence:
.
The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to devices currently manufactured and marketed by COOK INCORPORATED. This device is similar with respect to indications for use, materials and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.