(49 days)
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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March 26, 2018
Biopsybell s.r.l. % Mr. Maurizio Pantaleoni CEO Isemed s.r.l Via Togliatti 19/X, Imola (BO) 40026, ITALY
Re: K180315
Trade/Device Name: DISKOM Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: February 1, 2018 Received: February 5, 2018
Dear Mr. Pantaleoni:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180315
Device Name
DISKOM
Indications for Use (Describe)
The DISKOM is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thorace and cervical regions of the spine
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Summary of the K180315 DISKOM
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
General Information 1.
| Submitter : | Biopsybell s.r.l |
|---|---|
| Via A. Manuzio n.24 | |
| 41037, Mirandola (MO), Italy |
Establishment Registration Number: 9617616
| Consultant/ Contact: | Maurizio Pantaleoni |
|---|---|
| Isemed srl | |
| Via Togliatti 19/X | |
| Imola (BO) 40026, ITALY | |
| Mob. +39 348 4435155 | |
| Tel. +39 0542 683803 | |
| Fax +39 0542 698456 | |
| Email: regulatory@isemed.eu |
Summary Prepared Date: 2018-02-01
-
- Names
Device Name: Classification Name: Product Code: Regulation number: CLASS:
- Names
DISKOM ARTHROSCOPE HRX 888.1100 ll
3. Predicate Devices
The DISKOM is substantially equivalent to the following devices legally marketed in US:
| Applicant | Device name | 510(k) Number | Product code |
|---|---|---|---|
| GALLINI | Herniatome Percutaneous Discectomy Device | K141557 | HRX |
| STRYKER | Stryker Decompressor Percutaneous Discectomy Probe | K032473 | HRX |
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4. Device Description
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).
5. Indications for Use
The DISKOM is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine.
| Subject device | Predicate device (K141557) | Predicate device (K032473) | |
|---|---|---|---|
| Product Name | DISKOM | Herniatome PercutaneousDiscectomy Device | Stryker DecompressorPercutaneous Discectomy Probe |
| Manufacturer | BIOSPYBELL S.R.L. | GALLINI | STRYKER |
| 510(K) No. | - | K141557 | K032473 |
| Regulation Name | Arthroscope | Arthroscope | Arthroscope |
| Regulation Number | 888.1100 | 888.1100 | 888.1100 |
| Classification | II | II | II |
| Product Code | HRX | HRX | HRX |
| Intended Use | |||
| Indications for use | The Diskom is intended for use inaspiration of disc material duringpercutaneous discectomies in thelumbar, thoracic and cervicalregions of the spine. | The Herniatome PercutaneousDiscectomy Device is intendedfor use in aspiration of discmaterial during percutaneousdiscectomies in the lumbar,thoracic, and cervical regionsof the spine. | The Dekompressorpercutaneous Discectomy Probeis intended for use in aspirationof disc material duringpercutaneous discectomies inthe lumbar, thoracic andcervical regions of the spine. |
| Technical features | |||
| Single Use Device | YES | YES | YES |
| Power | DC Motor - 9 Volt Battery | DC Motor - Battery | DC Motor - 9 Volt Battery |
| Maximum use time | 10 minutes | Unknown | 10 minutes |
| Configuration | Single use device with:- introducer needle composed byan external cannula and introducerstylet- Discectomy probe composed by astylet with screw, a collectioncontainer and a grip with internalbattery source DC motor- The stylet has 2 screws that enablethe collection of disc material | Single use device with:- introducer needle composedby an external cannula andinternal stylet- Discectomy probe composedby a stylet with screw, acollectioncontainerandinternal battery source DCmotor | Single use device with:- introducer needle composedby an external cannula andinternal stylet- Discectomy probe composedby a stylet with screw, acollection container and internalbattery source DC motor- the stylet has 2 screws in thedevice with length 3" and 6" and3 screws in the one with length9" |
| Dimensions ofcannula(length / gauge) | 16 cm / 17 gauge(thoracic / lumbar) | 15 cm / 17 gauge (lumbar) | 6" (15.24 cm) / 17 gauge (alsoavailable 13,15,19 gauge) -(thoracic / lumbar)9" (22,86 cm) / 17 gauge(lumbar) |
| 8 cm / 19 gauge (cervical) | 9 cm / 17 gauge (cervical) | 3" (7.62 cm) / 19 gauge(cervical) | |
| Aspiration cannulahole position | Lateral hole | Lateral hole | Frontal hole |
| Materials | |||
| Introducer Stylet | AISI 304 stainless steel | Stainless steel | Unknown |
| Cannula | AISI 304 stainless steel | Stainless steel | Unknown |
| Stylet with screw | Titanium | Stainless steel | Titanium |
| Biocompatibility | |||
| Citotoxicity | Conforming to ISO 10993 testing(ISO 10993-5) | Conforming | Unknown |
| Sensitization | Conforming to ISO 10993 testing(ISO 10993-10) | Conforming | Unknown |
| IntracutaneousReactivity | Conforming to ISO 10993 testing(ISO 10993-10) | Conforming | Unknown |
| Acute Systemictoxicity | Conforming to ISO 10993 testing(ISO 10993-11) | Conforming | Unknown |
| Bacterial endotoxinstest (LAL test) | Conforming | Unknown | Unknown |
| Pyrogen test | Conforming | Unknown | Unknown |
| Electrical Safety / Electromagnetic Compatibility | |||
| Electrical Safety /ElectromagneticCompatibility | Conforming to:IEC 60601-1 for electrical safetyEN 60601-1-2 for ElectromagneticCompatibility | Conforming to:IEC 60601-1 electrical safetyIEC 60601-1-2 forElectromagnetic Compatibility | Conforming to:IEC 60601-1 for electrical safetyIEC 60601-1-2 forElectromagnetic Compatibility |
| Sterilization Shelf life | |||
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Shelf life | 3 years | 3 years | 3 years |
| Performance test for determination of the SE | |||
| Performance tests | The following performance tests have been performed on the device, both on newly manufactured and aged products:time of functioning (20 minutes) engine rpm quantity of tissue retrieved during the procedure battery shelf life maximum temperature at the level of the stylet with screw radiodetectability | The following performance tests have been performed on the device:volume flow rate study battery shelf life radiodetectability | Unknown |
6. Substantial equivalence discussion & Summary of Technological Characteristics
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510(K) SUMMARY
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510(K) SUMMARY
7. Performance Data
7.1 Non clinical tests performed on the subject device
The following comparative tests have been performed for all BIOPSYBELL DISKOM codes:
-
- Time of functioning (20 minutes). Battery operation test for 20 minutes
-
- Enqine rpm. Measurement of the number of rpm
-
- Quantity of tissue retrieved during the procedure.
-
- Battery shelf life: battery voltage measuring test during operation.
-
- Maximum Temperature at the level of the stylet with screw measurement
The radiodetectability was another parameter tested. The radiopacity has been tested on subject device and on predicate device. T
Furthermore the following Biocompatibility tests were performed:
- -Citotoxicity
- -Sensitization
- -Intracutaneous Reactivity
- -Acute Systemic toxicity
- -Bacterial endotoxins test (LAL test)
- -Pyrogen test
Based on technological characteristics (intended use, dimensions and features) and performance data (comparative tests and biocompatibility tests) included in the present submission, the BIOPSYBELL DISKOM has been shown to be substantially equivalent to the listed predicate device.
7.2 Clinical tests performed on the subject device No clinical test were performed on the subject device
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Conclusion 8
Based on technological characteristics (intended use, dimensions and features) and performance data (comparative tests and biocompatibility tests) and comparison discussion included in the present submission, the BIOPSYBELL DISKOM has been shown to be substantially equivalent to the listed predicate devices.
§ 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.