(49 days)
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No
The summary describes a mechanical device (shaver blades) and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of data sets or performance metrics typically associated with AI/ML.
No
The device, "Thermo-Plastic Shaver Blades," is designed for orthopedic use in surgical procedures (shaving), which is an interventional/diagnostic tool rather than a therapeutic one itself. Its function is to remove tissue rather than treat a disease or condition. It is equivalent to K940515, a surgical shaver.
No
The device description clearly states it is a "shaver blade" for orthopedic use, which is a surgical tool, not a device used to diagnose medical conditions.
No
The device description clearly states it consists of physical components (Thermo-Plastic and stainless steel tubes) and uses an electrical motor, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The description clearly states the device is a "Thermo-Plastic Shaver Blade" used for "orthopedic use." It involves a rotating blade used within the body during a surgical procedure.
- Intended Use: The intended use is for "orthopedic use" and "single use applications" during surgery. This is a surgical tool, not a diagnostic test performed on a sample.
The device is a surgical instrument used directly on the patient's body, not for analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
The disposable Thermo-Plastic Shaver Blades are for orthopedic use and will be provided sterile for single use applications.
Product codes
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Device Description
The Thermo-Plastic Shaver Blades, consisting of an inner Thermo-Plastic and stainless steel tube which rotates inside of a stainless steel tube through the use of an electrical motor in a handpiece, is equivalent in intended use, safety and effectiveness to existing Thermo-Plastic shaver blades, used in similar applications, by Linvatec.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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Image /page/0/Picture/0 description: This document appears to be a regulatory submission document, possibly related to medical devices. It includes information such as the device's current classification name, which is 'Arthroscope and accessories CFR 888.1100 Class II,' and the expanded classification name, which is 'Surgical instruments motors/accessories CFR 878.4820 Class I.' The document also lists the common name as 'Surgical Shaver' and the proprietary name as 'Thermo-Plastic Shaver Blade.' The document is dated 'OCT 11 1996' and includes the number 'k 963332'.
SUMMARY OF SAFETY AND EFFECTIVENESS FOR THERMO-PLASTIC SHAVER BLADES
:
Class II
The Thermo-Plastic Shaver Blade is substantially equivalent to the Linvater, Merlin Polyblade shaver manufactured by Linvatec per K940515.
The Thermo-Plastic Shaver Blades, consisting of an inner Thermo-Plastic and stainless steel tube which rotates inside of a stainless steel tube through the use of an electrical motor in a handpiece, is equivalent in intended use, safety and effectiveness to existing Thermo-Plastic shaver blades, used in similar applications, by Linvatec.
The disposable Thermo-Plastic Shaver Blades are for orthopedic use and will be provided sterile for single use applications. The material of construction, cutting action, availability of suction and tip configuration are equivalent to currently marketed products. As proven in arthroscopic applications, this design offers the required precision for controlling the location and extent of tissue resection.
The Thermo-Plastic Shaver Blades will use materials deemed to be biocompatible per ISO 10993 and the General Program Memorandum #G95-1. The disposable shaver blade is Gamma sterilized per AAMI ST32, SAL 10 . Packaging is validated per ASTM standards 4169, D999, D775, F88, D3078.
The Stryker Thermo-Plastic Shaver Blades do not raise any new safety and efficacy concerns when compared to a similar device marketed by Linvates. Therefore, the Stryker Thermo-Plastic Shaver Blades is substantially equivalent to the Linvatec, Merlin Polyblade shaver.
Kim Zoller
Regulatory Classification
Eric Finley Design Engineer
Enclosure