(164 days)
The Omnibone™ Bone Marrow Biopsy Kit is indicated for bone marrow aspiration and biopsy of the anterior or the posterior iliac crest of adult patients.
The Omnibone™ Bone Biopsy Kit is indicated for bone biopsy of the vertebral body and bone lesions.
The OmniBone™ Powered Biopsy System consists of a rechargeable Power Driver with Charger and compatible Biopsy Kits with Power Driver Pouch.
The OmniBone™ Bone Biopsy Kit with Power Driver Pouch and the OmniBone™ Bone Marrow Biopsy Kit with Power Driver Pouch are both provided sterile (EtO), are both single-use and are both designed exclusively for use with the OmniBone™ Power Driver. All OmniBone™ Biopsy Kits are available in different needle gauge sizes and lengths.
The OmniBone™ Power Driver with Charger is a handheld, Lith-on battery powered, and rechargeable Power Driver, reusable and supplied non-sterile.
The OmniBone™ Power Driver has a 3-position switch that controls the motion of the driver: reverse (counter clockwise) – off – forward (clockwise). The OmniBone™ Power Driver has a variable speed trigger that controls the speed of the driver. Applying light pressure on the trigger activates the driver at low speed and increasing the trigger pressure activates higher speeds. Full pressure on the trigger will activate full speed. No pressure on the trigger will stop the motor function. A charging LED indicates the level of charge of the battery of the OmniBone™ Power Driver. An integrated connector allows the OmniBone™ Power Driver to connect to the OmniBone™ Charger.
The provided text describes the regulatory clearance (K230015) for the OmniBone™ Bone Marrow Biopsy Kit with Power Driver and OmniBone™ Bone Biopsy Kit with Power Driver. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the level of detail requested for acceptance criteria and the comprehensive study design typically associated with proving a device meets those criteria for AI/ML-based medical devices.
The document is a 510(k) summary for a medical device (a biopsy kit with a power driver), not an AI/ML-driven diagnostic or assistive technology. Therefore, the "acceptance criteria" discussed are related to the mechanical, electrical, and biocompatibility performance of the physical device, not the performance metrics of an AI algorithm (like sensitivity, specificity, or reader improvement).
Therefore, I cannot fully answer your request based on the provided text, as it does not describe an AI/ML study.
However, I can extract the information related to the device's non-AI related performance testing and acceptance, interpreting "acceptance criteria" in the context of a physical medical device.
Based on the provided text, here's what can be inferred about the device's non-AI related performance and acceptance:
The document states that the OmniBone™ Powered Biopsy System "met all the predetermined acceptance of design verification and validation as specified by applicable standards, guidance, tests protocols and/or customer inputs." This is a general statement of acceptance, and the subsequent list outlines the types of tests performed to achieve this.
1. Table of Acceptance Criteria and Reported Device Performance (as inferred for a physical device):
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Mechanical/Functional Performance | - Battery charging time: Met predetermined acceptance. |
| - Battery capacity: Met predetermined acceptance. | |
| - Rotation Speed: Met predetermined acceptance. | |
| - Needle Penetration Force: Met predetermined acceptance. | |
| - Power Driver Coupler Reliability: Met predetermined acceptance. | |
| - Tensile Strength – Needle hub: Met predetermined acceptance. | |
| - Creep Testing: Met predetermined acceptance. | |
| - Dead Space Measurements: Met predetermined acceptance. | |
| - Tissue sampling: Met predetermined acceptance. | |
| Biocompatibility | - Biocompatibility testing performed in accordance with ISO 10993-1. |
| Sterility | - Sterilization performed in accordance with ISO 11135:2014 to confirm SAL of 10-6. |
| Shelf Life | - Label shelf life: 5 years. |
| Electrical Safety & EMC | - Electromagnetic Compatibility and Electrical Safety Testing performed on Power Driver and Charger in accordance with IEC 60601-2. |
| - Met electrical safety and performance requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not explicitly stated. The document lists the types of tests performed (e.g., "Battery charging time," "Tissue sampling," "Needle Penetration Force") but does not provide specific sample sizes (e.g., number of batteries tested, number of needles, number of tissue samples).
- Data Provenance: Not specified. This typically refers to the source of data for clinical studies (e.g., patient demographics, geographical locations). For this type of device testing, it would refer to the conditions under which the engineering tests were conducted (e.g., in-house lab, third-party lab). The document does not provide this detail.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable for this type of device submission. The ground truth for these engineering performance tests is typically established by direct measurement against engineering specifications and industry standards, not by expert consensus (like radiologists reviewing images).
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for AI/ML validation where human readers establish ground truth from complex data like medical images. This document describes physical device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a physical biopsy device without an AI component.
6. If a Standalone (Algorithm Only) Performance Was Done:
- No. This device is a physical instrument, not an standalone algorithm.
7. The Type of Ground Truth Used:
- For the physical performance tests (e.g., speed, force, battery metrics): Engineering specifications and industry standards.
- For biocompatibility: ISO 10993-1 standards and associated biological endpoints.
- For sterility: ISO 11135:2014 standard for Ethylene Oxide sterilization, confirming SAL (Sterility Assurance Level).
- For electrical safety/EMC: IEC 60601-2 standards and associated electrical performance/safety thresholds.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
In summary: The provided FDA 510(k) summary focuses on the substantial equivalence of a physical medical device. It successfully outlines the types of engineering and laboratory tests conducted to ensure the device's safety and performance against established standards, but these are distinct from the types of studies and acceptance criteria applicable to AI/ML software.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 16, 2023
Laurane Medical SAS
Mr. Laurent Fumex Head of Company Chemin de la bayette ZAC de la bayette Le Pradet, 83220 France
Re: K230015
Trade/Device Name: OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver
Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: May 4, 2023 Received: May 8, 2023
Dear Mr. Fumex:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.06.16
08:22:14 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230015
Device Name
-
Omnibone™ Bone Marrow Biopsy Kit with Power Driver
-
Omnibone™ Bone Biopsy Kit with Power Driver
Indications for Use (Describe)
The Omnibone™ Bone Marrow Biopsy Kit is indicated for bone marrow aspiration and biopsy of the anterior or the posterior iliac crest of adult patients.
The Omnibone™ Bone Biopsy Kit is indicated for bone biopsy of the vertebral body and bone lesions.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Laurane Medical. The logo consists of a green square with a black curved line on the left side, followed by a purple square with a white "L" inside. To the right of the squares is the text "Laurane" in black, with the word "Medical" in a smaller font size below it.
K230015 Laurane Medical SAS Chemin de la Bayette ZAC de la Bayette 83220 Le Pradet France
510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based as follows:
1. Submitter Information:
| Applicant: | Laurane Medical SASChemin de la BayetteZAC de la BayetteLe Pradet 83220 - FRANCE |
|---|---|
| Phone :Fax : | 860-399-9900860-399-9200Contact : Laurent Fumexlfumex@lauranemedical.com: Laurane.medical@wanadoo.fr |
3 January 2023 Date :
2. Subject Device Name :
| Device Trade Name : | OmniBone™ Bone Marrow Biopsy Kit with Power DriverOmniBone™ Bone Biopsy Kit with Power Driver |
|---|---|
| Common Name: | Bone Marrow Biopsy KitBone Biopsy Kit |
| Classification: | Class IIKNW (Gastroenterology - urology biopsy instrument) |
| Review Panel: | Gastroenterology / Urology |
| Regulation Number: | 21 CFR 876.1075 |
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Image /page/4/Picture/0 description: The image is a logo for Laurane Medical. The logo features a stylized letter "L" in black, with a green square behind it. To the right of the "L" is a purple square with a white "L" inside. The text "Laurane" is written in black, and the word "Medical" is written in a smaller font below it.
3. Predicate Device
| Device Trade Name: | OnControl™ Bone Access and Bone Biopsy System by Vidacare®OnControl™ Bone Marrow Biopsy System by Vidacare® |
|---|---|
| 510(k) Number: | K113872, K142377 |
| Common/Usual Name: | Cement Dispenser Conduit for Vertebroplasty and Bone BiopsyNeedle, Bone Marrow Biopsy Needle |
| Classification: | Class IIKNW (Gastroenterology - Urology biopsy instrument) |
| Regulation number: | 21 CFR 876.1075 |
4. Subject Indications for Use:
The OmniBone™ Bone Biopsy Kit with Power Driver is indicated for bone biopsy of the vertebral body and bone lesions.
The OmniBone™ Bone Marrow Biopsy kit with Power Driver is indicated for bone marrow aspiration and biopsy of the anterior or the posterior iliac crest of adult patients.
5. Subject Device Description
The OmniBone™ Powered Biopsy System consists of a rechargeable Power Driver with Charger and compatible Biopsy Kits with Power Driver Pouch.
The OmniBone™ Bone Biopsy Kit with Power Driver Pouch and the OmniBone™ Bone Marrow Biopsy Kit with Power Driver Pouch are both provided sterile (EtO), are both single-use and are both designed exclusively for use with the OmniBone™ Power Driver. All OmniBone™ Biopsy Kits are available in different needle gauge sizes and lengths.
The OmniBone™ Power Driver with Charger is a handheld, Lith-on battery powered, and rechargeable Power Driver, reusable and supplied non-sterile .
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Image /page/5/Picture/0 description: The image is a logo for Laurane Medical. The logo features a stylized letter "L" in black, with a green square behind it. To the right of the green square is a purple square with a white "L" inside. The text "Laurane" is written in black to the right of the squares, and the word "Medical" is written in a smaller font below it.
The OmniBone™ Power Driver has a 3-position switch that controls the motion of the driver: reverse (counter clockwise) – off – forward (clockwise). The OmniBone™ Power Driver has a variable speed trigger that controls the speed of the driver. Applying light pressure on the trigger activates the driver at low speed and increasing the trigger pressure activates higher speeds. Full pressure on the trigger will activate full speed. No pressure on the trigger will stop the motor function. A charging LED indicates the level of charge of the battery of the OmniBone™ Power Driver. An integrated connector allows the OmniBone™ Power Driver to connect to the OmniBone™ Charger.
6. Technological Comparison to Predicate Device
The table below provides a technological comparison between the subject device and the predicate device.
| Characteristic | PredicateOnControl™ Powered Bone AccessSystemOnControl™ Bone Marrow Biopsy System -K142377OnControl™ Bone Access and Bone BiopsySystem - K113872 | SubjectOmniBone™ Powered BiopsySystemOmniBone™ Bone Marrow Biopsy kit withPower DriverOmniBone™ Bone Biopsy kit with PowerDriver | |
|---|---|---|---|
| Regulation Number | 21 CFR 876.1075 | 21 CFR 876.1075 | |
| Class | II | II | |
| Primary FDA Product Code | KNW - Instrument, BiopsyFCG -Biopsy Needle | KNW - Instrument, Biopsy | |
| Indications for Use | BoneMarrow | The OnControl™ Bone Marrow BiopsySystem is intended for bone marrowaspiration and biopsy in adult andpediatric patients age 2 and older. | The OmniBone™ bone marrow biopsy kitis indicated for bone marrow aspirationand biopsy of the anterior or the posterioriliac crest of adult patients. |
| BoneLesion | The OnControl™ Bone Access andBone Biopsy System is intended for usewith a standard cement deliverysystem for the fixation of fractures ofthe vertebral body usingvertebroplasty and/or for bone biopsyof the vertebral body and bone lesions. | The OmniBone™ Bone Biopsy Kit withPower Driver is intended for bone biopsyof the vertebral body and bone lesions. |
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Image /page/6/Picture/0 description: The image shows the logo for Laurane Medical. The logo consists of a stylized letter "L" in black, with a green square behind it. To the right of the "L" is the word "Laurane" in black, with the word "Medical" in a smaller font below it. The logo is simple and modern, and the colors are calming and professional.
| K230015 | ||
|---|---|---|
| Characteristic | PredicateOnControl™ Powered Bone AccessSystemOnControl™ Bone Marrow Biopsy System -K142377OnControl™ Bone Access and Bone BiopsySystem - K113872 | SubjectOmniBone™ Powered BiopsySystemOmniBone™ Bone Marrow Biopsy kit withPower DriverOmniBone™ Bone Biopsy kit with Power Driver | |
|---|---|---|---|
| Target Population | BoneMarrow | Adult and pediatric patients needingbone marrow aspiration or bonemarrow biopsy. | Adult patients needing bone marrowaspiration or bone marrow biopsy. |
| BoneLesion | Patients requiring fixation of fracturesof the vertebral body or bone biopsy. | Patients requiring bone biopsy. | |
| Fundamental ScientificTechnology | Power Driver with NeedleAttachments | Power Driver with Needle Attachments | |
| Power Driver Design | Cordless, lithium battery-powered;reusable with disposable sterile sleeve | Cordless, lithium battery-powered;reusable with disposable sterilesleeve | |
| Power Driver Energy Delivered | Non rechargeable, Internal, 18 VLithium Battery | Rechargeable, Internal, 4.2 V LithiumBattery | |
| Power DriverCybersecurity/Interfaces | Does not contain any external wiredand/or wired communicationinterfaces | Does not contain any external wiredand/or wired communicationinterfaces | |
| Charger | No charger | Charger for power driver with DC powerplug | |
| Needle Design | Sterile, single-use, disposable | Sterile, single-use, disposable | |
| Operating Principle | Needle set attaches to batterypowered driver | Needle set attaches to battery powereddriver | |
| Mode of Action | Single puncture, bone access, andsample | Single puncture, bone access, and sample | |
| Energy Used / Delivered | Lithium battery provides rotationalkinetic energy to aid the physician ininserting and advancing the needlethrough cortical and/or cancellousbone | Lithium-on battery provides rotationalkinetic energy to aid the physician ininserting and advancing the needlethrough cortical and/or cancellousbone | |
| Imaging Compatibility | X-Ray / CT and UltrasoundCompatibility | X-Ray / CT and Ultrasound Compatibility |
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Image /page/7/Picture/0 description: The image shows the logo for Laurane Medical. The logo consists of a stylized "L" shape in black, placed next to a green square with a purple square inside containing the letter "L" in white. To the right of the squares, the word "Laurane" is written in black, with the word "Medical" written in a smaller font size below it.
| K230015 | ||
|---|---|---|
| Characteristic | PredicateOnControl™ Powered Bone AccessSystemOnControl™ Bone Marrow Biopsy System -K142377OnControl™ Bone Access and Bone BiopsySystem - K113872 | SubjectOmniBone™ Powered BiopsySystemOmniBone™ Bone Marrow Biopsy Kit withPower DriverOmniBone™ Bone Biopsy Kit with PowerDriver | |
|---|---|---|---|
| Speed | Single-Speed | Variable | |
| Power Driver Motion | Forward motion | Reverse and forward motion | |
| KitComponents | Bone Marrow | OnControl™ Bone Marrow Biopsy Tray- Alignment Guide- Biopsy Needle- Depth Stop- Ejector Rod- Connector Hub with Sterile Sleeve- Fenestrated Drape | OmniBone™ Bone Marrow Biopsy Kitwith Power Driver Pouch● Needle set:Biopsy Cannula and Stylet with depthgauge (Biopsy Needle Assembly)- Ejector Pin- Ejector guide● Pouch set:- Power Driver Pouch- Coupler |
| Bone Lesion | OnControl™ Bone Lesion Biopsy Tray- Transfer Rod- Bone Access Ejector Rod- Bone Access Needle Set- Bone Lesion Biopsy Needle- Bone Lesion Biopsy EjectorRod- Depth Stop- Manual Handle- Connector Hub with SterileSleeve- Fenestrated Drape- Ejector Assistant | OmniBone™ Bone Biopsy Kit with PowerDriver Pouch● Needle set:- Bone Access Introducer (Outer cuttingCannula + Drill tip Stylet + depthgauge assembly)- Trephine Biopsy Needle (TrephineOuter Cannula + Stiffener + depthgauge assembly)- Ejector Pin- Handle- Holder● Pouch set:- Power Driver Pouch- Coupler | |
| Gauge Sizes | Bone Marrow | Biopsy Cannula:11G | Biopsy Cannula: 11G |
| Bone Lesion | Access Cannula:10G and 11GBiopsy Cannula:12G and 13G | Introducer Cannula:11GTrephine Outer Cannula:13G | |
| Characteristic | PredicateOnControl™ Powered Bone AccessSystemOnControl™ Bone Marrow Biopsy System -K142377OnControl™ Bone Access and Bone BiopsySystem - K113872 | SubjectOmniBone™ Powered BiopsySystemOmniBone™ Bone Marrow Biopsy Kit withPower DriverOmniBone™ Bone Biopsy Kit with Power Driver | |
| OverallNeedleAssemblyLength | Bone Marrow | Biopsy Needle Assembly:102 and 152 mm | Biopsy Needle Assembly: 100and 150 mm |
| Bone Lesion | Bone Access Needle Assembly: 62,102 and 152 mm | Bone Access Introducer Assembly:65,5, 106 and 156 mm | |
| Bone Lesion | Biopsy Needle Assembly:108, 148, and 198 mm | Biopsy Trephine Assembly:154,194,5 and 234,5mm | |
| Biopsy Kits - Sterility | Single Use, Ethylene Oxide | Single Use, Ethylene Oxide | |
| Power Driver - Sterility | Reusable, non-sterile.Used with Single Use Disposable SterileSleeve with Connector Hub | Reusable, non-sterile.Used with Single Use DisposableSterile Pouch and Coupler | |
| Power Driver - Disinfection | Disinfected utilizing an antimicrobialsolution | Disinfected utilizing an antimicrobialsolution |
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Image /page/8/Picture/0 description: The image is a logo for Laurane Médical. The logo features a stylized "L" in black, with a green square behind it. To the right of the "L" is the word "Laurane" in black, with the word "Médical" in a smaller font below it. The "L" is partially contained within a purple square.
The predicate device is the OnControl™ Powered Bone Access System, which is comprised of the OnControl™ Bone Marrow Biopsy System and the OnControl™ Bone Access and Bone Biopsy System. The OnControl™ Powered Bone Access System is referenced as the predicate device for the OmniBone™ Powered Biopsy System as it is the same or similar to the subject device in the following ways:
a. Intended Use
b. Indications for Use
- The OmniBone™ Bone Biopsy Kit with Power Driver shares the same indications for use as the predicate OnControl™ Bone Access and Bone Biopsy System as they share a subset of the OnControl™ Bone Access and Bone Biopsy System. The subject device and the predicate device are both indicated for the sampling of bone biopsies from the vertebral body and from bone lesions. Indications for vertebroplasty have been omitted.
- The OmniBone™ Bone Marrow Biopsy Kit with Power Driver shares the same indications for use as the predicate OnControl Bone Marrow Biopsy System as they are both indicated for bone marrow aspiration and biopsy in adult patients. Indication for pediatric patients has been omitted.
c. Target population
- d. Fundamental Scientific Technology
- e. Performance characteristics
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Image /page/9/Picture/0 description: The image is a logo for Laurane Medical. The logo features a stylized letter "L" in black, with a green square behind it. To the right of the "L" is the word "Laurane" in black, with the word "Medical" in a smaller font below it. The logo is simple and modern, and the colors are calming and professional.
- f. Operating Principle, Mechanism of action
- g. Sterility Assurance Level and method of Sterilization
The subject device is different from the predicate device in the following ways:
-Enhanced Power Driver Technology
- a. Variable Speed Functionality: The subject device utilizes a variable speed Power Driver. The variable speed functionality was designed to allow the user to control the speed of the needle rotation depending on their needs and the type of procedure being performed.
- b. The subject device's offers 2 possible driving motion: reverse and forward and is controlled by a 3-position switch. The addition of a reverse motion eases the introduction of the access needle through soft tissue and the removal of the needles from the bone.
- Reference LED Indicator that displays Power Level: The subject device utilizes a Reference ﻥ LED indicator that displays 3 level of Power Level.
- d. Rechargeable: the subject device has a DC jack connector and is rechargeable via a dedicated Charger.
- e. Driveshaft: the subject device has no driveshaft extending from the housing but a fully integrated female connector instead facilitating the cleaning of the Power Driver. This difference has no impact on mode of action or on safety.
Biopsy Kit Components
- Optimized Biopsy and Introducer Cannula Dimensions and Tip Design: The subject device a. Biopsy and Introducer Cannulas feature enhanced designs for optimal sample acquisitions.
- b. Unlike the connector sleeve of the Predicate, the subject device has a sterile pouch and a sterile coupler that are not factory-assembled together. The pouch and the coupler are assembled during the procedure. This design has no impact on the efficiency of the barrier-like system and shows the same level of performance and safety than the predicate.
- Handle Manual Driver (Bone Biopsy Kit ): The subject device's Manual Driver has a Handle ﻥ and attaches to the needle assembly via an interfacing and locking mechanism.
- d. Easy Connect Release Mechanism: The subject device is designed to release the Needle Assembly from the Power Driver by simply pressing the releasable locking fins of the Luer-Hub of the needles.
7. Performance Data
The OmniBone™ Powered Bone Biopsy System which includes the OmniBone™ Power Driver, the OmniBone™ Charger, the OmniBone™ Bone Biopsy Kit with Power Driver Pouch and the OmniBone™ Bone Marrow Biopsy Kit with Power Driver Pouch was tested to evaluate its performances and support the determination of substantial equivalence.
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Image /page/10/Picture/0 description: The image is a logo for Laurane Medical. The logo features a stylized "L" shape in black, placed over a green square. To the right of the green square is a purple square with a white "L" inside. The text "Laurane" is written in black to the right of the squares, and the word "Medical" is written in a smaller font below "Laurane".
The following tests were performed on the subject device:
- Battery charging time -
- Battery capacity -
- -Tissue sampling
- Reliability Testing Power Driver Pouch Sealing -
- Rotation Speed -
- -Needle Penetration Force
- Power Driver Coupler Reliability -
- -Tensile Strength – Needle hub
- Creep Testing -
- Dead Space Measurements -
Additionally, biocompatibility testing was performed in accordance with ISO 10993-1 to demonstrate that the OmniBone™ Powered Biopsy System is biocompatible for its intended use. Sterilization was performed in accordance with ISO 11135:2014 to confirm the Sterility Assurance Level (SAL) of 10-6 for the OmniBone™ Biopsy Kits. The label shelf life is 5 years. Electromagnetic Compatibility and Electrical Safety Testing were performed on the OmniBone™ Power Driver and Charger in accordance with IEC 60601-2. The results from this testing demonstrate that the OmniBone™ Power Driver and Charger meets electrical safety and performance requirements established, and acceptance criteria for all tests were met. The subject device OmniBone™ Powered Biopsy system (OmniBone™ Power Driver, OmniBone™ Charger, OmniBone™ Bone Biopsy Kit with Power Driver Pouch, OmniBone™ Bone Marrow Biopsy Kit with Power Driver Pouch) met all the predetermined acceptance of design verification and validation as specified by applicable standards, guidance, tests protocols and/or customer inputs.
8. Conclusion
The proposed OmniBone™ Powered Biopsy System (OmniBone™ Power Driver, OmniBone™ Charger, OmniBone™ Bone Biopsy Kit with Power Driver Pouch, OmniBone™ Bone Marrow Biopsy Kit with Power Driver Pouch) and the predicate share the same or similar intended use, indications for use, target population, technological characteristics and fundamental scientific technology. Therefore, Laurane Medical SAS has demonstrated that the subject device OmniBone™ Powered Biopsy System (OmniBone™ Power Driver, OmniBone™ Charger, OmniBone™ Bone Biopsy Kit with Power Driver Pouch, OmniBone™ Bone Marrow Biopsy Kit with Power Driver Pouch) is substantially equivalent to the legally marketed predicate device OnControl™ Bone Marrow Biopsy System and OnControl™ Bone Access and Bone Biopsy System, respectively.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. 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 § 876.9.