DISKOM

K180315 · Biopsybell S.R.L. · HRX · Mar 26, 2018 · Orthopedic

Device Facts

• Record ID: K180315
• Device Name: DISKOM
• Applicant: Biopsybell S.R.L.
• Product Code: HRX · Orthopedic
• Decision Date: Mar 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DISKOM is intended for use in aspiration of disc material during percutaneous discectomies in the lumbar, thorace and cervical regions of the spine

Device Story

DISKOM is a single-use, battery-powered discectomy probe used by specialized personnel in clinical settings. It functions with an introducer needle (cannula and stylet) positioned via CT or fluoroscopic guidance. Once the cannula is placed, the stylet is removed and the probe is inserted. The probe utilizes a DC motor to drive an internal screw conveyor mechanism, which excises and retrieves nucleus pulposus tissue through the cannula into a transparent collection container. The device aids in spinal decompression procedures. It is provided in various cannula lengths and gauges to accommodate different spinal regions. The healthcare provider uses the device to mechanically remove disc material, potentially relieving pressure on spinal nerves.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including functional performance (time of functioning, engine RPM, tissue retrieval quantity, battery shelf life, maximum temperature), radiodetectability, and biocompatibility testing (ISO 10993-5, -10, -11).

Technological Characteristics

Single-use, battery-powered (9V DC motor) discectomy probe. Materials: AISI 304 stainless steel (cannula/stylet), titanium (stylet screw). Dimensions: 8-16cm length, 17-19G. Sterilization: Ethylene Oxide. Electrical safety: IEC 60601-1; EMC: EN 60601-1-2. Mechanical screw-conveyor principle for tissue aspiration.

Indications for Use

Indicated for patients requiring aspiration of disc material during percutaneous discectomies in lumbar, thoracic, and cervical spine regions.

Regulatory Classification

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.

Predicate Devices

• Herniatome Percutaneous Discectomy Device (K141557)
• Stryker Decompressor Percutaneous Discectomy Probe (K032473)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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. [phone] |
| | Tel. [phone] |
| | Fax [phone] |
| | Email: [e-mail] |

Summary Prepared Date: 2018-02-01

- 2. Names
Device Name: Classification Name: Product Code: Regulation number: CLASS:

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 Percutaneous<br>Discectomy Device | Stryker Decompressor<br>Percutaneous 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 in<br>aspiration of disc material during<br>percutaneous discectomies in the<br>lumbar, thoracic and cervical<br>regions of the spine. | The Herniatome Percutaneous<br>Discectomy Device is intended<br>for use in aspiration of disc<br>material during percutaneous<br>discectomies in the lumbar,<br>thoracic, and cervical regions<br>of the spine. | The Dekompressor<br>percutaneous Discectomy Probe<br>is intended for use in aspiration<br>of disc material during<br>percutaneous discectomies in<br>the lumbar, thoracic and<br>cervical 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:<br>- introducer needle composed by<br>an external cannula and introducer<br>stylet<br>- Discectomy probe composed by a<br>stylet with screw, a collection<br>container and a grip with internal<br>battery source DC motor<br>- The stylet has 2 screws that enable<br>the collection of disc material | Single use device with:<br>- introducer needle composed<br>by an external cannula and<br>internal stylet<br>- Discectomy probe composed<br>by a stylet with screw, a<br>collection<br>container<br>and<br>internal battery source DC<br>motor | Single use device with:<br>- introducer needle composed<br>by an external cannula and<br>internal stylet<br>- Discectomy probe composed<br>by a stylet with screw, a<br>collection container and internal<br>battery source DC motor<br>- the stylet has 2 screws in the<br>device with length 3" and 6" and<br>3 screws in the one with length<br>9" |
| Dimensions of<br>cannula<br>(length / gauge) | 16 cm / 17 gauge<br>(thoracic / lumbar) | 15 cm / 17 gauge (lumbar) | 6" (15.24 cm) / 17 gauge (also<br>available 13,15,19 gauge) -<br>(thoracic / lumbar)<br><br>9" (22,86 cm) / 17 gauge<br>(lumbar) |
| | 8 cm / 19 gauge (cervical) | 9 cm / 17 gauge (cervical) | 3" (7.62 cm) / 19 gauge<br>(cervical) |
| Aspiration cannula<br>hole 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<br>(ISO 10993-5) | Conforming | Unknown |
| Sensitization | Conforming to ISO 10993 testing<br>(ISO 10993-10) | Conforming | Unknown |
| Intracutaneous<br>Reactivity | Conforming to ISO 10993 testing<br>(ISO 10993-10) | Conforming | Unknown |
| Acute Systemic<br>toxicity | Conforming to ISO 10993 testing<br>(ISO 10993-11) | Conforming | Unknown |
| Bacterial endotoxins<br>test (LAL test) | Conforming | Unknown | Unknown |
| Pyrogen test | Conforming | Unknown | Unknown |
| Electrical Safety / Electromagnetic Compatibility | | | |
| Electrical Safety /<br>Electromagnetic<br>Compatibility | Conforming to:<br>IEC 60601-1 for electrical safety<br>EN 60601-1-2 for Electromagnetic<br>Compatibility | Conforming to:<br>IEC 60601-1 electrical safety<br>IEC 60601-1-2 for<br>Electromagnetic Compatibility | Conforming to:<br>IEC 60601-1 for electrical safety<br>IEC 60601-1-2 for<br>Electromagnetic 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:<br>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:<br>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:

- 1. Time of functioning (20 minutes). Battery operation test for 20 minutes
- 2. Enqine rpm. Measurement of the number of rpm
- 3. Quantity of tissue retrieved during the procedure.
- 4. Battery shelf life: battery voltage measuring test during operation.
- 5. 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.