(581 days)
Not Found
No
The description focuses on the mechanical and electrical aspects of an ultrasonic surgical system and does not mention any AI or ML components or functionalities.
Yes
The device is used for soft tissue incisions and coagulation, which is a therapeutic intervention, and the intended use states it can be an adjunct or substitute for other surgical tools.
No
The device is described as an "Ultrasonic Surgical System" used for soft tissue incisions, cutting, and coagulation, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly lists hardware components such as a generator, foot switch, scalpel, hand piece, and optional cart, indicating it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "soft tissue incisions when bleeding control and minimal thermal injury are desired." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details components like a generator, foot switch, scalpel, and hand piece, all of which are consistent with a surgical instrument. It explains how electrical energy is converted to mechanical motion for cutting and coagulating tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on the analysis of these samples.
Therefore, the K500 Ultrasonic Surgical System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
Ultrasonic Surgical System consists of a generator, a foot switch, a scalpel and a hand piece. In addition, a cart is provided as an optional component. The electrical energy supplied by the generator will be converted into mechanical motion by the transducer in hand piece, which will drive the scalpel vibrate longitudinally. The foot switch is used to control the activation of energy output. The scalpels are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue
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)
Nonclinical performance comparison tests were conducted to verify that the proposed device met all design specifications. The tests performed on the subject device included testing and evaluation for vessel burst pressure, thermal spread, acute animal vessel sealing study, and chronic animal survival study.
The biocompatibility tests were performed on the proposed device. Based on the contact level and contact duration, the proposed device was tested for skin sensitization (ISO 10993-10), intracutaneous reactivity (ISO 10993-10), cytotoxicity (ISO 10993-5), pyrogenicity (ISO 10993-11) and system toxicity (ISO 10993-11).
Electrical safety and EMC test was conducted on the proposed device per AAMI/ANSI ES 60601-1, IEC 60601-2-18 and IEC 60601-1-2.
The following testing demonstrated that the subject device complies with the following standards:
- AAMI/ANSI/ ES 60601-1:2005/(R)2012 and A1: 2012, C1:2009(R)2012 and A2:2010(R)2012(Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
- IEC 60601-2-18:2009 Medical electric equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests;
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity;
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ASTM F88/F88M-15 Standard method for seal strength of flexible barrier materials
- GB18280:2007 (IDT ISO 11137: 2006)
No clinical study is included in this submission.
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.
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
N/A
0
September 30, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Miconvey Technologies Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K210567
Trade/Device Name: Ultrasonic Surgical System Regulatory Class: Unclassified Product Code: LFL Dated: August 29, 2022 Received: August 29, 2022
Dear Diana Hong:
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 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
1
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,
Colin K. Chen, Ph.D. Acting 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration
Indications for Use
510(k) Number (if known) K210567
Device Name K500 Ultrasonic Surgical System
Indications for Use (Describe)
The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ā Prescription Use (Part 21 CFR 801 Subpart D) | ā Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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3
K210567 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
-
- Date of Preparation: 09/26/2022
-
- Sponsor Identification
Miconvey Technologies Co., Ltd.
No.16 Fangzheng Avenue, Beibei District, Chongqing, 400714, China
Establishment Registration Number: Not yet registered
Contact Person: Kang Li Position: General Manager Tel: +86-23-63171596 Fax: +86-23-63171516 Email: kang.li@miconvey.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: K500 Ultrasonic Surgical System Common Name: Ultrasonic Surgical Generator and Accessory Model: K500
Regulatory Information: Classification Name: Instrument, Ultrasonic Surgical Classification: Unclassified; Pre-amendment Product Code: LFL; Regulation Number: N.A. Review Panel: General& Plastic Surgery;
Indication for Use Statement:
The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels.
Device Description
Ultrasonic Surgical System consists of a generator, a foot switch, a scalpel and a hand piece. In addition, a cart is provided as an optional component. The electrical energy supplied by the generator will be converted into mechanical motion by the transducer in hand piece, which will drive the scalpel vibrate longitudinally. The foot switch is used to control the activation of energy output. The scalpels are used to cut and coagulate soft bodily tissues and structures in many surgery procedures.
5. Identification of Predicate Devices
Primary Predicate Device
510(k) Number: K002906 Product Name: Ultracision Harmonic Scalpel System Model Name: GEN04 Manufacturer: Ethicon Endo-Surgery, LLC
Secondary Predicate Device
510(k) Number: K042777 Product Name: Harmonic ACETM Curved Shears with Hand Control
5
Manufacturer: Ethicon Endo-Surgery, LLC
6. Summary of Technological Characteristics
| Item | Proposed Device | Primary Predicate Device | Remark |
|---|---|---|---|
| Product Code | LFL | LFL | Same |
| Classification | Unclassified | Unclassified | Same |
| Regulation Number | N.A. | N.A. | Same |
| Intended Use | The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels. | The Ultracision Harmonic Scalpel System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The Ultracision Harmonic Scalpel System instruments can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels. | Same |
| Configuration | Generator | Generator | Same |
| Footswitch | Foot Switch | Same | |
| Hand piece | Hand piece | Same | |
| Scalpel | N.A. | Different | |
| Sterile | Generator- Nonsterile | Generator- Nonsterile | Same |
| Handpiece- Nonsterile. Sterilization required prior to use. | Handpiece- Nonsterile. Sterilization required prior to use. | Same | |
| Scalpel-Provided sterile | N.A. | Different | |
| Biocompatibility | No Patient Contact Material | No Patient Contact Material | Same |
| Electrical Safety | Comply with AAMI/ANSI/ ES | ||
| 60601-1 | Comply with IEC 60601-1 | Same | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
| Table 2 Comparison of Technology Characteristics- Ultrasonic Surgical System-Scalpel | |||
| Item | Proposed Device | Secondary Predicate Device | Remark |
| Product Code | LFL | K042777 | |
| LFL | Same | ||
| Classification | Unclassified | Unclassified | Same |
| Regulation Number | N.A. Pre-Amendment | N.A. Pre-Amendment | Same |
| Intended Use | The K500 Ultrasonic Surgical System is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The scalpel can be used as an adjunct or substitute for electrosurgery, laser and steel scalpels. | The Harmonic ACETM Curved Shears with Hand Control is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures. | Same |
| Shaft length | 14cm, 23cm and 36cm | 23cm and 36cm | Different |
| Pin hole to proximal end | 18.85mm | 18.85mm | Same |
| Pin hole diameter | 1.8mm | 1.8mm | Same |
| Tip diameter | 2.14mm | 2.16mm | Similar |
| Jaw diameter | 5.45mm | 5.45mm | Same |
| Rotary head length | 2.9mm | 2.9mm | Same |
| Handle length | 36.9mm | 37mm | Similar |
| Handle width | 30.05mm | 30mm | Similar |
| Closing trigger width | Upper width: 3.2mm | ||
| Lower width: 7mm | Upper width: 3.2mm | ||
| Lower width: 7mm | Same | ||
| Trigger button length | 2.2mm | 2.2mm | Same |
| Torque wrench diameter | 8.15mm | 8.15mm | Same |
| Shaft diameter | 3.42mm | 3.42mm | Same |
| Blade shape | Curved | Curved | Same |
| Energy Type | Ultrasonic and Mechanical | Ultrasonic and Mechanical | Same |
| Sterility | 10-6 SAL | 10-6 SAL | Same |
| Single Use | Single Use | Single Use | Same |
| Biocompatibility | Pass | Pass | Same |
| Electrical Safety | Comply with AAMI/ANSI/ES | ||
| 60601-1 | Comply with IEC 60601-1 | Same | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same |
Table 1 Comparison of Technology Characteristics- Ultrasonic Surgical System
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Table 2 Comparison of Technology Characteristics- Ultrasonic Surgical System-Scalpel
7
Different-Shaft Length
The proposed scalpel is available in three shaft length 14cm, 23cm and two shaft length models are covered in predicate device. The different shaft length does not affect the indication of soft tissue incisions.
Similar-Tip Diameter
The tip diameter for the proposed device is different from predicate device. In addition, this difference is very slight and animal study has been conducted on the subject device and predicate device. The animal study result showed there were no significant difference.
Similar-Handle Length and Handle Width
The handle length and width for the proposed device is different from predicate device. In addition, this difference is very slight and does not affect intended use.
-
- Software
Software verification and validation testing were conducted, and documentation was provided in accordance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Software
-
- Summary of Non-clinical Performance Testing
Nonclinical performance comparison tests were conducted to verify that the proposed device met all design specifications. The tests performed on the subject device included testing and evaluation for vessel burst pressure, thermal spread, acute animal vessel sealing study, and chronic animal survival study.
- Summary of Non-clinical Performance Testing
The biocompatibility tests were performed on the proposed device. Based on the contact level and contact duration, the proposed device was tested for skin sensitization (ISO 10993-10), intracutaneous reactivity (ISO 10993-10), cytotoxicity (ISO 10993-5), pyrogenicity (ISO 10993-11) and system toxicity (ISO 10993-11).
Electrical safety and EMC test was conducted on the proposed device per AAMI/ANSI ES 60601-1, IEC 60601-2-18 and IEC 60601-1-2.
8
The following testing demonstrated that the subject device complies with the following standards:
-
AAMI/ANSI/ ES 60601-1:2005/(R)2012 and A1: 2012, C1:2009(R)2012 and A2:2010(R)2012(Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
-
IEC 60601-2-18:2009 Medical electric equipment- Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- A IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests;
-
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity;
- A ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity A
-
ASTM F88/F88M-15 Standard method for seal strength of flexible barrier materials
-
GB18280:2007 (IDT ISO 11137: 2006)
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Conclusion
The conclusions drawn from the subject device indications for use, technological characteristics and performance testing demonstrates that the subject device is as safe and effective as and is substantially equivalent to the legally marketed predicate devices.
- Conclusion