(13 days)
Not Found
No
The summary describes a bipolar electrosurgical device that uses radiofrequency energy for tissue resection and coagulation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an electrosurgical probe used in arthroscopic and orthopedic procedures for resection, coagulation, and hemostasis of soft tissue and blood vessels, which are all therapeutic interventions aimed at treating medical conditions.
No
Explanation: The device is described as an electrosurgical probe used for resection, coagulation, and hemostasis of soft tissue and blood vessels during surgical procedures. Its function is to deliver radiofrequency energy for treatment, not to diagnose conditions.
No
The device description clearly states it is a bipolar device designed to direct radiofrequency energy, indicating it is a hardware device (electrosurgical probe) and not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease.
- Device Description and Intended Use: The NuOrtho CERULEAU™ Probes are described as electrosurgical probes used during surgical procedures (arthroscopic and orthopedic) for the direct treatment of tissue (resection, coagulation, hemostasis). They are not used to analyze specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic information being generated from the device's output, or any of the typical components or processes associated with IVD devices (e.g., reagents, assays, specimen handling).
The device is a surgical instrument used for therapeutic purposes during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
NuOrtho CERULEAU™ Probes are intended for use as surgical instruments.
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 |
| 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 |
Product codes (comma separated list FDA assigned to the subject device)
GEI, HRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, elbow, hip, knee, shoulder, wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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 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.
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.
K011083, K991960, K002422, K993885, K012018
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
§ 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.
0
K 1 01711
Page 1 of (4)
NuOrtho Surgical, Inc.
ip
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 Summary | ||
| Prepared: | June 30th 2010 | JUL -1 2010 |
| Device Trade Name: | CERULEAU™ Electrosurgical Probe | |
| Common Name: | Electrosurgical Probe | |
| Classification Name: | Electrosurgical cutting and coagulation device and | |
| accessories | ||
| 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 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. | ||
| Intended and | ||
| Indications for Use: | NuOrtho CERULEAU™ Probes are intended for use as | |
| surgical instruments. | ||
| 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: |
1
K1017"
Page 2 of 4
.
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 |
2
K 1017"
Page 3 of (4)
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
3
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.
4
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
5
Page 2 - Mr. Mark Job
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
6
Page 1 of 2
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
Page 11
7
Page 2 of (2)
NuOrtho Surgical, Inc.
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