(13 days)
The NuOrtho CERULEAU™ Probes are indicated for resection, coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. These procedures include the following indications: Resection and Excision (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoid Labrum, Labral Tear, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons).
The CERULEAU™ Electrosurgical Probe is a bipolar device designed to direct radiofrequency energy from an electrosurgical generator into target tissue during arthroscopic and orthopedic surgical procedures. Ceruleau delivers non-ablation, low-level amounts of radiofrequency energy to the treatment site. The radiofrequency energy is delivered via a protected electrode geometry which inhibits direct electrode-to-tissue contact. Design of the electrode's protective housing can function as a mechanical implement for use adjunct to energy delivery.
The NuOrtho Surgical, Inc. CERULEAU™ Electrosurgical Probe is a bipolar device intended for resection, coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the CERULEAU™ Electrosurgical Probe. Instead, the performance testing focuses on demonstrating "substantial equivalence" to predicate devices and proving that its design "consistently and significantly reduces incidence of damage to collateral and subject tissues."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to currently marketed predicate devices for intended use. | "Performance testing... provides support that the CERULEAU™ Electrosurgical Probe is substantially equivalent to currently marketed predicate devices." This is a general claim and not specific performance metrics. |
| Compliance with relevant standards for design, labeling, packaging, and sterilization. | The device is compliant with ANSI/AAMI ISO 11137-1, ISO 11607-1, ISO 11607-2, ASTM F1980-07, ASTM D4169, ISO 10993-5, ISO 10993-10, ISO 10993-11, IEC 60601-1, and IEC 60601-2-2. |
| Effectiveness of probe performance compared to predicate devices in arthroscopic/orthopedic surgery. | A comparison study (REP-100-1210) was conducted to evaluate the effectiveness. The summary indicates that it provides support for substantial equivalence, but specific quantitative results of the comparison are not detailed in this summary. The full report is in Appendix 12. |
| Clinical efficacy and extent of collateral damage, particularly for chondroplasty. | A comparative evaluation (REP-100-1220) "provides clear histological evidence to substantiate that, as compared to predicates, the design and use of the CERULEAU™ Probe consistently and significantly reduces incidence of damage to collateral and subject tissues." It "proves that, due to its design, the CERULEAU™ Probe consistently performs to reduce incidence of damage to collateral and subject tissues." The predicate devices are described as "inherently prone to cause damage to collateral and subject tissues." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the sample size for the test set used in studies REP-100-1210 and REP-100-1220.
- Data Provenance:
- REP-100-1210 is described as including "bench and in vitro human data."
- REP-100-1220 was "conducted in-vitro on excised human tissue."
- The country of origin for the human tissue or the studies is not specified. Both studies are retrospective in the sense that they are laboratory/bench studies, not prospective clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. For histological evidence (REP-100-1220), it would be expected that a qualified pathologist would be involved, but this is not explicitly stated.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or human readers being involved with or without AI assistance. The studies described are focused on the device's direct performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an electrosurgical probe, which is a physical surgical tool, not an algorithm. Therefore, the concept of an "algorithm only without human-in-the-loop performance" study does not apply to this device. The studies described evaluate the physical performance of the probe (e.g., tissue effects).
7. Type of Ground Truth Used
- For study REP-100-1220, the ground truth for evaluating "incidence of damage to collateral and subject tissues" was histological evidence derived from excised human tissue.
- For REP-100-1210, which evaluated "effectiveness of the CERULEAU™ Probe performance," the specific ground truth is not detailed but would likely involve measurements of resection, coagulation, or hemostasis efficacy in a bench/in vitro setting, compared to predicate devices.
8. Sample Size for the Training Set
The document does not mention a training set in the context of device development or performance evaluation. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the method for establishing its ground truth is not applicable to this submission.
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NuOrtho Surgical, Inc.
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CERULEAU™ Electrosurgical Probe Traditional 510(k)
5. 510(K) SUMMARY
| CERULEAU™ Electrosurgical Probe - 510(k) Summary | ||
|---|---|---|
| Submitter: | NuOrtho Surgical, Inc. | |
| Contact: | Roy Morgan, PE, PMP | |
| Date SummaryPrepared: | June 30th 2010 | JUL -1 2010 |
| Device Trade Name: | CERULEAU™ Electrosurgical Probe | |
| Common Name: | Electrosurgical Probe | |
| Classification Name: | Electrosurgical cutting and coagulation device andaccessories | |
| Classification Code: | 21 CFR §878.4400 Product Code: GEI | |
| Equivalent Device(s): | ArthroCare Arthrowands (K011083) Stryker SERFAS (K991960) Mitek VAPR S90 (K002422) ConMed UltrAblator (K993885) ConMed Bicap Superconductor™ (K012018) | |
| Device Description: | The CERULEAU™ Electrosurgical Probe is a bipolardevice designed to direct radiofrequency energy from anelectrosurgical generator into target tissue duringarthroscopic and orthopedic surgical procedures.Ceruleau delivers non-ablation, low-level amounts ofradiofrequency energy to the treatment site. Theradiofrequency energy is delivered via a protectedelectrode geometry which inhibits direct electrode-to-tissue contact. Design of the electrode's protectivehousing can function as a mechanical implement for useadjunct to energy delivery. | |
| Intended andIndications for Use: | NuOrtho CERULEAU™ Probes are intended for use assurgical instruments.The NuOrtho CERULEAU™ Probes are indicated forresection, coagulation of soft tissue and hemostasis ofblood vessels in arthroscopic and orthopedic procedures.These procedures include the following indications: |
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K1017"
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.
CERULEAU™ Electrosurgical Probe
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints(ankle, elbow, hip, knee, shoulder, and wrist) |
|---|---|
| Resection and Excision | |
| Acetabular Labrum | Hip |
| Articular Labrum | All Joints |
| Capsule | All Joints |
| Capsular Release | Knee |
| Cartilage Flaps | Knee |
| Cysts | All Joints |
| Discoid Meniscus | Knee |
| Frozen Shoulder Release | Shoulder |
| Glenoid Labrum | Shoulder |
| Labral Tear | Shoulder |
| Lateral Release | Knee |
| Ligament | All Joints |
| Loose Bodies | All Joints |
| Meniscal Cystectomy | Knee |
| Meniscectomy | Knee |
| Plica Removal | All Joints |
| Scar Tissue | All Joints |
| Soft Tissue | All Joints |
| Synovial Membrane | All Joints |
| Tendon | All Joints |
| Triangular Fibrocartilage (TFCC) | Wrist |
| Villusectomy | Knee |
| Debridement | |
| ACL/PCL | Knee |
| Acromioplasty | Shoulder |
| Articular Cartilage | All Joints |
| Bursectomy | All Joints |
| Chondroplasty | All Joints |
| Fascia | All Joints |
| Ligament | All Joints |
| Notchplasty | Knee |
| Scar Tissue | All Joints |
| Soft Tissue | All Joints |
| Subacromial Decompression | Shoulder |
| Synovectomy | All Joints |
| Tendon | All Joints |
| Coagulation | |
| ACL/PCL | Knee |
| Articular Cartilage | All Joints |
| Carpal Ligaments | Wrist |
| Glenohumeral Capsule | Shoulder |
| Ligament | All Joints |
| Medial Retinaculum | Knee |
| Rotator Cuff | Shoulder |
| Tendon | All Joints |
| Wrist Tendons | Wrist |
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CERULEAU™ Electrosurgical Probe Traditional 510(k)
Non-clinical Performance Data:
Performance testing per standardized methods and NSI test protocols including bench and in vitro human data was conducted and provides support that the CERULEAU™ Electrosurgical Probe is substantially equivalent to currently marketed predicate devices. Non-clinical performance test protocols and results are included in sections 14 through 18 of this 510(k) submission. Test protocols and reports of results demonstrate that. in consideration of its intended use, the design, labeling, packaging and sterilization of the CERULEAU™ Electrosurgical Probe is compliant with the following standards:
- ANSI/AAMI ISO 11137-1:2006 (Cor 1:2007) , . Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 11607-1:2006-04-15 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier
- . ISO 11607-2: 1st Edition-2006-04-15; Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes, including Annex B (informative) listing of standardized test methods and procedures
- ASTM F1980-07; Shelf-life and accelerated aging . techniques for standard evaluation of packaging performance
- . ASTM D4169 (2009):Standard Test Method for Testing of Shipping Containers and Systems
- . ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity .
- ISO 10993-10:2002 (A1:2006). Biological evaluation of . medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity.
- t ISO 10993-11:2006, Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.
- IEC 60601-1; Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance.
- IEC 60601-2-2- 2009. Medical electrical equipment -. Part 2-2: Particular requirements for the safety of high frequency surgical equipment
Section 18, (Bench testing) includes a summary of a comparison study (REP-100-1210) that was conducted to evaluate the effectiveness of the CERULEAU™ Probe performance to other legally available probes intended for similar usage in arthroscopic and orthopedic surgery. The full
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CERULEAU™ Electrosurgical Probe Traditional 510(k)
report of REP-100-1210 entitled "Evaluation of Ceruleau™ Performance on Human tissue -Establishment of Clinically Relevant Functional Substantial Equivalence" is provided in Appendix 12.
Section 18 also includes a summary of REP-100-1220 entitled, "Comparative_Evaluation of Ceruleau™ Chondroplasty Performed on Excised Human Articular Cartilage -
Assessment of Clinical Efficacy and Extent of Collateral Damage", which was conducted invitro on excised human tissue and is provided in Appendix 12.
The REP-100-1220 provides clear histological evidence to substantiate that, as compared to predicates, the design and use of the CERULEAU™ Probe consistently and significantly reduces incidence of damage to collateral and subject tissues. The study proves that, due to its design, the CERULEAU™ Probe consistently performs to reduce incidence of damage to collateral and subject tissues, while the designs of the predicate devices are inherently prone to cause damage to collateral and subject tissues. Additionally, Section 21 includes a summary of scientific publications that support the need for the technological features and clinical utility of the CERULEAU Electrosurgical Probe.
Clinical Performance Data:
Clinical data was not necessary to support that the CERULEAU™ Electrosurgical Probe is substantially equivalent to currently marketed predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 1 2010
NuOrtho Surgical, Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K101711
Trade/Device Name: Ceruleau™ Electrosurgical Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HRX Dated: June 17, 2010 Received: June 18, 2010
Dear Mr. Job:
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 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 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
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
Mark A. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CERULEAU™ Electrosurgical Probe Traditional 510(k)
4. INDICATIONS FOR USE STATEMENT
510(k) Number if known: N/A
Device Name: CERULEAU™Electrosurgical Probe
The NuOrtho CERULEAU™ Probes are indicated for resection, coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
These procedures include the following indications:
| Arthroscopic and Orthopedic Procedures | Joint Specific or All Joints(ankle, elbow, hip, knee, shoulder, and wrist) |
|---|---|
| Resection and Excision | |
| Acetabular Labrum | Hip |
| Articular Labrum | All Joints |
| Capsule | All Joints |
| Capsular Release | Knee |
| Cartilage Flaps | Knee |
| Cysts | All Joints |
| Discoid Meniscus | Knee |
| Frozen Shoulder Release | Shoulder |
| Glenoid Labrum | Shoulder |
| Labral Tear | Shoulder |
| Lateral Release | Knee |
| Ligament | All Joints |
| Loose Bodies | All Joints |
| Meniscal Cystectomy | Knee |
| Meniscectomy | Knee |
| Plica Removal | All Joints |
| Scar Tissue | All Joints |
| Soft Tissue | All Joints |
| Synovial Membrane | All Joints |
| Tendon | All Joints |
| Triangular Fibrocartilage (TFCC) | Wrist |
| Villusectomy | Knee |
| Debridement | |
| ACL/PCL | Knee |
| Acromioplasty | Shoulder |
| Articular Cartilage | All Joints |
| Bursectomy | All Joints |
| Chondroplasty | All Joints |
| Facia | All Joints |
| Ligament | All Joints |
| Notchplasty | Knee |
| Scar Tissue | All Joints |
| Soft Tissue | All Joints |
| Subacromial Decompression | Shoulder |
| Synovectomy | All Joints |
| Tendon | All Joints |
| Coagulation | |
| ACL/PCL | Knee |
K1017
Number
(k)
ision Sign-Off)
Restoralive Devices
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CERULEAU™ Electrosurgical Probe Traditional 510(k)
| Coagulation (continued) | |
|---|---|
| Articular Cartilage | All Joints |
| Carpal Ligaments | Wrist |
| Glenohumeral Capsule | Shoulder |
| Ligament | All Joints |
| Medial Retinaculum | Knee |
| Rotator Cuff | Shoulder |
| Tendon | All Joints |
| Wrist Tendons | Wrist |
Prescription Use __X (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (Per 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101711
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.