(88 days)
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Not Found
No
The device description and intended use clearly define the product as a collection of standard medical components for administering anesthesia. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance testing described is for a physical component (catheter connector), not a software-based system.
No
The device is described as a compilation of preparatory and surgical components for administering anesthesia, not for treating a condition or disease.
No
Explanation: The device is described as a compilation of preparatory and surgical components required for administering anesthesia, not for diagnosing a condition.
No
The device description explicitly states it is a compilation of physical components like needles, syringes, and catheters, packaged in a plastic tray. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer to a patient regional or local anesthesia." This is a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device is a collection of surgical components used for administering anesthesia. These components are used in vivo (within the body) during a medical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue), detect analytes, or provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
SIMS' Regional Anesthesia Trays are used to administer to a patient regional or local anesthesia.
Product codes
73CAZ
Device Description
Regional Anesthesia Trays cover a broad product range, including; Continuous Epidural, Single Shot Epidural, Spinal, Nerve Block, Pediatric Epidural, and Combined Spinal/Epidural Trays. These trays are a compilation of the preparatory and surgical components required for administering anesthesia. The trays may include components such as: needles, syringes, filters, catheters, gloves, gauze sponges, drapes, The components are placed into a plastic tray, wrapped in CSR wrap, sealed, and sterilized by ethylene oxide. The trays are available in standard component configurations or can be customized to meet the needs of an individual user. All componentry supplied in these kits are from an approved list of components which are legally marketed devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the epidural catheter connector was performed in accordance with BS 6196. Performance testing of the proposed modification to the epidural catheter connector demonstrates that it performed equal to or better than our current epidural catheter connector.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Continuous Epidural Tray, without Drugs, Full Kits ., Continuous Epidural Tray, with Drugs, Full Kits ., . Continuous Epidural Tray, without Drugs, Mini-Pack, Single Shot Epidural Tray, without Drugs ., Single Shot Epidural Tray, with Drugs ., B-D Whitacre Spinal Trays, without Drugs ., B-D Whitacre Spinal Trays, with Drugs ., . B-D Quincke Spinal Trays, with Drugs, Pediatric Continuous Epidural/Caudal Systems ●, Pediatric Single Shot Epidural/Caudal Systems ., Combined Epidural/Spinal Trays, without Drugs ., Combined Epidural/Spinal Trays, with Drugs ., Catheter Connector
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
SMITHS INDUSTRIES K9a501
Medical Systems
H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY
COMPANY INFORMATION
Smiths Industries Medical Systems, Inc. 15 Kit Street Keene, NH 03431 (603) 352-3812 x457 (603) 357-5038 Timothy J. Talcott Manager of Regulatory Affairs
PREPARATION DATE OF SUMMARY
December 13, 1996
TRADE NAME
None
COMMON NAME
Regional Anesthesia Trays
CLASSIFICATION NAME
Class II. 73CAZ, 21 CFR 868.5140
Note: This device may also be classified under General Hospital as a "prolonged contact device, >24 hours to 30 days.
PREDICATE DEVICE
The proposed modification to our Regional Anesthesia Trays is substantially equivalent to the predicate devices:
- Continuous Epidural Tray, without Drugs, Full Kits .
- Continuous Epidural Tray, with Drugs, Full Kits .
- . Continuous Epidural Tray, without Drugs, Mini-Pack
- Single Shot Epidural Tray, without Drugs .
- Single Shot Epidural Tray, with Drugs .
- B-D Whitacre Spinal Trays, without Drugs .
- B-D Whitacre Spinal Trays, with Drugs .
- . B-D Quincke Spinal Trays, with Drugs
- Pediatric Continuous Epidural/Caudal Systems ●
- Pediatric Single Shot Epidural/Caudal Systems .
- Combined Epidural/Spinal Trays, without Drugs .
- Combined Epidural/Spinal Trays, with Drugs .
- Catheter Connector
SIMS Inc.
人源,
15 Kit Street Keene, NH 03431 Telephone: (603) 352-3812 Fax: (603) 352-3703
1 4 1997
1
DESCRIPTION
Regional Anesthesia Trays cover a broad product range, including; Continuous Epidural, Single Shot Epidural, Spinal, Nerve Block, Pediatric Epidural, and Combined Spinal/Epidural Trays. These trays are a compilation of the preparatory and surgical components required for administering anesthesia. The trays may include components such as: needles, syringes, filters, catheters, gloves, gauze sponges, drapes, The components are placed into a plastic tray, wrapped in CSR wrap, sealed, and sterilized by ethylene oxide.
The trays are available in standard component configurations or can be customized to meet the needs of an individual user. All componentry supplied in these kits are from an approved list of components which are legally marketed devices.
INDICATIONS FOR USE
SIMS' Regional Anesthesia Trays are used to administer to a patient regional or local anesthesia.
TECHNOLOGICAL CHARACTERISTICS
All components used in our Regional Anesthesia Trays are legally marketed devices. The inclusion of these components in these trays will have the same biocompatibility implications as their current usage. The modified epidural catheter connector housing is constructed of the same materials as is currently used in the device. The insert does not contact the patient or the fluid path, as such, there are not coxicological implications with the insert.
SUMMARY OF PERFORMANCE DATA
Testing of the epidural catheter connector was performed in accordance with BS 6196. Performance testing of the proposed modification to the epidural catheter connector demonstrates that it performed equal to or better than our current epidural catheter connector.
SUMMARY OF NONCLINICAL AND CLINICAL TESTS
There were no nonclinical or clinical tests submitted with this submission.
CONCLUSION OF NONCLINICAL AND CLINICAL TESTS
There were no nonclinical or clinical tests submitted with this submission:
ADDITIONAL INFORMATION
None
Very truly vours.
Smiths Industries Medical Systems, Inc. dba Concord/Portex
Timothy J. Jackson
Timothy J. Talcott Manager of Regulatory Affairs