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510(k) Data Aggregation
(132 days)
Medline Microdissection Needle (4cm) (140936 (ESE104A)); Medline Microdissection Needle (3cm) (140937
The Medline Microdissection Needle is a monopolar electrosurgical instrument used for precision soft tissue dissection. It is a single-use device intended for cutting, dissecting, and cauterizing soft tissue. The Medline Microdissection Needle is not intended for use in the central nervous system or in the central circulatory system.
The Medline Microdissection Needle is a sterile, active electrode that is also referred to as a needle. It is designed for precision cutting, dissecting, and cauterization. The device is comprised of stainless steel, tungsten, and polyolefin heat shrink and will be offered in two different lengths, 4 cm (140936/ESE104A) and 3 cm (140937/ESE103A). The Medline Microdissection Needle is intended for connection with multiple brands of standard cautery pencils, including 510(k)-cleared Medline Cautery Pencil (K190643).
The Medline Microdissection Needle is a medical device and is not an AI/ML powered device, therefore no information about AI/ML acceptance criteria or studies is available in the provided text.
The provided document describes the 510(k) premarket notification for the Medline Microdissection Needle, comparing it to a predicate device. This submission process focuses on demonstrating substantial equivalence to a legally marketed device rather than establishing new acceptance criteria or conducting studies in the way one might for a novel AI/ML product.
Here's a breakdown of the non-clinical testing performed to demonstrate substantial equivalence, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of specific acceptance criteria with numerical performance targets in the way an AI/ML product might. Instead, it demonstrates equivalence through a comparison of technological characteristics and various non-clinical tests. The "Comparison Analysis" column in Table 1 serves as the "reported device performance" against the predicate device's characteristics.
| Device Characteristic | Proposed Device Performance | Predicate Device Characteristic | Comparison Analysis |
|---|---|---|---|
| Product Name | Medline Microdissection Needle | Stryker Colorado Microdissection Needle® | N/A |
| 510(k) Reference | K242370 | K033232 | N/A |
| Manufacturer | Applied Medical Coatings (for proposed device) | Stryker | N/A |
| Product Code | GEI | GEI | Same |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery | Same |
| Classification Name | Electrosurgical Cutting & Coagulation & Accessories | Electrosurgical Cutting & Coagulation & Accessories | Same |
| Regulation Number | 878.4400 | 878.4400 | Same |
| Indication for Use | Monopolar electrosurgical instrument for precision soft tissue dissection; single-use for cutting, dissecting, and cauterizing soft tissue; not for CNS or central circulatory system. | Monopolar electrosurgical instrument for precision soft tissue dissection (e.g., tonsillectomy, blepharoplasty); single-use for cutting, dissecting, and cauterizing soft tissue; not for CNS or central circulatory system. | Same – Both devices for precision soft tissue dissection and for cutting, dissecting, and cauterizing soft tissues. |
| Materials | Tube: Stainless Steel; Tip/Needle: Tungsten; Insulation: Polyolefin heat shrink; Tip Protector: PVC Compound; Tip Protector Colorant: Ethylene Vinyl Acetate | Tube: Stainless Steel; Tip/Needle: Tungsten; Insulation: Polyolefin (latex free); Non-stick coating: Isolation PTFE | Similar: Minor differences in materials of construction are addressed via biological safety testing per ISO 10993-1 and functional testing. The differences do not alter the safety and effectiveness of the product. |
| Design Features | Ultra-sharp (5 µm) tungsten needle that transfers current from electrosurgical generator to very small tissue surface area. | Ultra-sharp (5 µm) needle that transfers current from electrosurgical generator to very small tissue surface area. PTFE coating on tip to reduce eschar build up. | Similar: Functional testing, including thermal zone damage testing and tip/pencil compatibility testing on the subject device demonstrate the differences do not alter the safety and effectiveness of the product. |
| Active Accessory | Compatible with a variety of standard monopolar electrosurgical hand pieces. | Compatible with a variety of standard monopolar electrosurgical hand pieces. | Same |
| Single Use vs. Reusable | Single-Use | Single-Use | Same |
| Sterile vs. Non-Sterile | Sterile (EO) | Sterile (EO) | Same |
| OTC vs Rx | Rx only | Rx only | Same |
| Shelf Life | 3 years | 5 years | Different: Shelf-life testing supports the proposed expiration date through evaluation of the packaging integrity for maintaining device sterility and/or evaluation of any changes to device performance or functionality. |
| Dimensions | ESE103A: 51.75 ± 1.78 mm; ESE104A: 61.75 ± 1.78 mm; Outer Shaft Diameter: 2.36 ± 0.1 mm | Not explicitly stated for predicate in table, but discussed in comparison. | Functional testing, including thermal zone damage testing and tip/pencil compatibility, was performed on the subject device to ensure the differences do not alter the safety and effectiveness of the product. |
| Connector Type | Stainless Steel Tube | Stainless Steel Tube | Same |
| Performance Specifications | Rated Supply Voltage: 4000Vpeak; Max Power Output: 30 watts | Rated Supply Voltage: 5400 V; Max Power Output: 50 watts | Functional testing, including thermal zone damage testing and IEC 60601-2-2 was performed on the subject device to ensure the differences do not alter the safety and effectiveness of the product. |
| Compatibility | IFU advises verifying compatibility of all instruments and accessories, always with monopolar electrosurgical generators and accessories tested to IEC 60601 and EN 60601 standards. Compatible with any active handle with same or lower rated accessory voltage and complies with IEC 60601-2-2 given proper and secure fit. | IFU advises using with regulatory cleared and approved generators compatible with monopolar electrosurgical devices. Fits most cautery handpieces with a standard 2.4 mm or 1.6 mm shaft. | Similar |
2. Sample Size Used for the Test Set and Data Provenance:
The document primarily describes non-clinical bench testing, biocompatibility testing, electrical safety, and stability testing. It does not involve a "test set" of patient data or clinical images in the context of an AI/ML device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable as typically understood for AI/ML studies.
For bench tests, sample sizes would relate to the number of devices tested to meet statistical significance for particular tests (e.g., thermal damage, compression, dimensional measurements). These specific numbers are not detailed in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is not an AI/ML study involving human expert ground truth. The "ground truth" for this device's performance is established by adherence to recognized standards and validated physical/electrical performance tests.
4. Adjudication Method for the Test Set:
Not applicable. There is no human adjudication process described as this is not an AI/ML study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices, especially those incorporating AI, to assess the impact of the device on human reader performance. The Medline Microdissection Needle is a surgical instrument.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The Medline Microdissection Needle is a physical electrosurgical instrument used by a surgeon, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the Medline Microdissection Needle is established through:
- Adherence to recognized international standards: e.g., ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 11135, ISO 11607, ASTM F1980, ANSI/AAMI ST 72, USP , IEC 60601 series.
- Physical and Electrical Performance Specifications: Demonstrated through bench testing (Thermal Damage Zone Testing, Tip/Pencil Compatibility, Appearance, Dimensional Measurements, Compression Test, Electrical Safety, EMC testing).
- Biocompatibility Testing: Evaluating potential biological responses through various ISO 10993 tests.
- Stability (Shelf Life) Testing: Demonstrating integrity over the proposed shelf life.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML product.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This is not an AI/ML product.
In summary, the provided document focuses on demonstrating that the Medline Microdissection Needle is substantially equivalent to a predicate device through comprehensive non-clinical testing against established engineering and biological standards, rather than through AI/ML specific performance metrics like accuracy, sensitivity, or human reader improvement.
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