Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on a mechanical aspiration system driven by a DC motor, with no mention of AI or ML capabilities. The performance studies are also focused on mechanical and biocompatibility aspects.

Therapeutic

No
The DISKOM is used to remove disc material during discectomy procedures, which is an interventional procedure rather than a therapeutic treatment in itself according to the provided information.

Diagnostic

No

The DISKOM is described as a device for aspirating disc material during percutaneous discectomies, acting as a "screw conveyor to remove and retrieve the excised debris of the spine." This function is therapeutic, involving the removal of tissue, rather than diagnostic, which would involve identifying or characterizing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like an introducer needle, discectomy probe, battery source, DC motor, and collection container, indicating it is a hardware device with mechanical functions.

IVD (In Vitro Diagnostic)

Based on the provided information, the DISKOM device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "aspiration of disc material during percutaneous discectomies in the lumbar, thoracic and cervical regions of the spine." This describes a surgical procedure performed directly on the patient's body to remove tissue.
Device Description: The description details a mechanical device used for tissue removal during surgery. It involves an introducer needle, a discectomy probe with a motor and screw conveyor, and a collection container. This is a surgical instrument.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to provide diagnostic information about a patient's condition. IVDs are used to examine specimens in vitro (outside the body) to diagnose diseases or conditions.
Anatomical Site: The device is used directly on the spine, which is an in vivo (within the body) application.

In summary, the DISKOM is a surgical device used for tissue removal during a discectomy procedure, not a device used for in vitro diagnostic testing of biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

HRX

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar, thoracic and cervical regions of the spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

specialized personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical tests performed on the subject device:

Time of functioning (20 minutes). Battery operation test for 20 minutes
Engine 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
Radiodetectability
Biocompatibility tests: Citotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic toxicity, Bacterial endotoxins test (LAL test), Pyrogen test

No clinical test were performed on the subject device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K141557, K032473

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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);

1

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

1. 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
Discectomy Device	Stryker Decompressor
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
aspiration of disc material during
percutaneous discectomies in the
lumbar, thoracic and cervical
regions of the spine.	The Herniatome Percutaneous
Discectomy Device is intended
for use in aspiration of disc
material during percutaneous
discectomies in the lumbar,
thoracic, and cervical regions
of the spine.	The Dekompressor
percutaneous Discectomy Probe
is intended for use in aspiration
of disc material during
percutaneous discectomies in
the lumbar, thoracic and
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:

introducer needle composed by
an external cannula and introducer
stylet
Discectomy probe composed by a
stylet with screw, a collection
container and a grip with internal
battery source DC motor
The stylet has 2 screws that enable
the collection of disc material | Single use device with:
introducer needle composed
by an external cannula and
internal stylet
Discectomy probe composed
by a stylet with screw, a
collection
container
and
internal battery source DC
motor | Single use device with:
introducer needle composed
by an external cannula and
internal stylet
Discectomy probe composed
by a stylet with screw, a
collection container and internal
battery source DC motor
the stylet has 2 screws in the
device with length 3" and 6" and
3 screws in the one with length
9" |
| Dimensions of
cannula
(length / gauge) | 16 cm / 17 gauge
(thoracic / lumbar) | 15 cm / 17 gauge (lumbar) | 6" (15.24 cm) / 17 gauge (also
available 13,15,19 gauge) -
(thoracic / lumbar)

6. Substantial equivalence discussion & Summary of Technological Characteristics

5

510(K) SUMMARY

6

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
1. Enqine rpm. Measurement of the number of rpm
1. Quantity of tissue retrieved during the procedure.
1. Battery shelf life: battery voltage measuring test during operation.
1. 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

7

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.