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510(k) Data Aggregation
(49 days)
DISKOM
The DISKOM is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thorace and cervical regions of the spine.
The DISKOM is a single use, active, EO sterilized device, that shall be used by specialized personnel during discectomy procedures. The DISKOM is a disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus. DISKOM is composed by an INTRODUCER NEEDLE and a DISCECTOMY PROBE. The INTRODUCER NEEDLE is made of an aspiration cannula and an introducer stylet. The introducer needle is positioned on the disc (using CT / Fluoroscopic guide), then the stylet is removed and the cannula is used to position the discectomy probe. The DISCECTOMY PROBE contains a battery source DC motor that causes the internal mechanism to act as a screw conveyor to remove and retrieve the excised debris of the spine through the outer cannula and into the transparent collection container. The DISKOM is provided in two different models with two different cannula lengths (16cm and 8cm) and two different gauges cannulas (17G and 19G).
The DISKOM device, a percutaneous discectomy device for aspiration of disc material, was evaluated through non-clinical performance and biocompatibility testing. No clinical studies were performed.
Here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA's review for this 510(k) notification focused on establishing substantial equivalence to predicate devices, rather than setting specific numerical acceptance criteria for clinical performance. The acceptance criteria were primarily based on demonstrating comparable technological characteristics, intended use, and satisfactory performance in non-clinical tests.
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Intended Use | Aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine. | The DISKOM is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine. (Matches predicate devices and stated intended use). |
| Technological Characteristics (Comparison to Predicates) | Single-Use Device | YES (Comparable to predicates) |
| Power (DC Motor - Battery) | DC Motor - 9 Volt Battery (Comparable to K032473, specific voltage provided). | |
| Maximum Use Time | 10 minutes (Comparable to K032473). | |
| Configuration (Introducer needle, discectomy probe with screw, collection container, DC motor grip) | Single use device with: introducer needle (external cannula and introducer stylet), Discectomy probe (stylet with screw, collection container, grip with internal battery source DC motor), stylet has 2 screws. (Comparable to predicates, with minor variations in screw count). | |
| Dimensions of Cannula (length/gauge) | 16 cm / 17 gauge (thoracic/lumbar); 8 cm / 19 gauge (cervical) (Comparable range and common gauges to predicates). | |
| Aspiration Cannula Hole Position | Lateral hole (Comparable to K141557, different from K032473 which has a frontal hole, but deemed substantially equivalent). | |
| Materials (Introducer Stylet, Cannula, Stylet with screw) | AISI 304 stainless steel (Introducer Stylet, Cannula); Titanium (Stylet with screw) (Comparable to predicates, some more specific details provided). | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Conforming to ISO 10993 testing. |
| Sensitization (ISO 10993-10) | Conforming to ISO 10993 testing. | |
| Intracutaneous Reactivity (ISO 10993-10) | Conforming to ISO 10993 testing. | |
| Acute Systemic Toxicity (ISO 10993-11) | Conforming to ISO 10993 testing. | |
| Bacterial Endotoxins Test (LAL test) | Conforming. | |
| Pyrogen Test | Conforming. | |
| Electrical Safety / EMC | Electrical Safety (IEC 60601-1) | Conforming to IEC 60601-1. |
| Electromagnetic Compatibility (EN 60601-1-2) | Conforming to EN 60601-1-2. | |
| Sterilization & Shelf Life | Sterilization Method | Ethylene Oxide (Comparable to predicates). |
| Shelf Life | 3 years (Comparable to predicates). | |
| Performance Tests (Non-clinical) | Time of functioning | Device operated for 20 minutes successfully. |
| Engine rpm | Measurement of engine RPM was performed (specific values not provided in summary, but assumed to be acceptable). | |
| Quantity of tissue retrieved | Testing performed (specific metrics or comparison not provided in summary, but assumed to be acceptable). | |
| Battery shelf life / Voltage measuring | Battery voltage measuring test during operation performed (assumed to be acceptable). | |
| Maximum temperature at stylet with screw | Measurement performed (assumed to be acceptable). | |
| Radiodetectability | Radiopacity tested on subject device and predicate device (assumed to be comparable and acceptable). |
2. Sample Size Used for the Test Set and Data Provenance
The summary indicates that non-clinical tests were performed. It does not specify a "test set" in the context of patient data or clinical images. For the performance tests, it mentions "all BIOPSYBELL DISKOM codes" were tested, and refers to "newly manufactured and aged products." The exact number of devices tested for each performance parameter is not specified.
- Sample Size: Not explicitly stated for each non-clinical test, but implied to be sufficient for demonstrating performance by testing "all BIOPSYBELL DISKOM codes" and both "newly manufactured and aged products."
- Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (Biopsybell s.r.l. in Italy). Therefore, there is no "country of origin of the data" in the clinical sense, and the data is generated specifically for this submission. The tests are prospective in nature, as they were conducted to obtain regulatory clearance.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable. This was a non-clinical study, so there was no "ground truth" established by experts in the context of clinical interpretation or diagnosis.
4. Adjudication Method for the Test Set
Not applicable, as there was no clinical test set requiring expert adjudication.
5. MRMC Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical test were performed on the subject device." Therefore, there is no effect size of human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The DISKOM device is a mechanical arthroscope/discectomy probe, not an artificial intelligence (AI) algorithm or software-only device. Its performance is related to its mechanical and electrical function, not an AI output.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by direct measurement and adherence to predefined engineering specifications and international standards. For example:
- Biocompatibility: Conformance to ISO 10993 standards.
- Electrical Safety/EMC: Conformance to IEC 60601-1 and EN 60601-1-2 standards.
- Performance tests: Measurements of parameters like run time, RPM, temperature, and radiopacity against internal design specifications and predicate device characteristics, as well as accepted engineering principles.
8. Sample Size for the Training Set
Not applicable. This device does not involve a training set as it is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device does not involve a training set.
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