(268 days)
K1312612, K101990
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a power generator for surgical dissectors, with no indication of AI capabilities.
Yes
The device is described as an "Ultrasonic Surgery Advanced Dissector and Portable Controller" intended for "vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures." It performs therapeutic actions like dissection, coagulation, and cutting tissues.
No
The device is described as providing power to drive surgical tools for tissue dissection, coagulation, and cutting. It is used for therapeutic procedures (vessel sealing, soft tissue incision) rather than for diagnosing a condition or disease.
No
The device description explicitly mentions physical components like a “portable controller (Cat. # SA10)” and “single patient use dissector (Cat. #s SASD14, SASD23, SASD36 and SASD45),” as well as mentions of “generator” functionality and “transducer.” It also details non-software performance studies such as cytotoxicity, electrical safety, electromagnetic compatibility, and ex vivo/in vivo studies, all of which pertain to hardware.
No.
The device is used for surgical procedures like vessel sealing and tissue incisions, which are therapeutic interventions rather than diagnostic in vitro tests.
N/A
Intended Use / Indications for Use
SA10 Portable Controller is intended to provide power to drive SanAgile™ Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired.
SanAgile™ Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures.
The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button.
Product codes
LFL
Device Description
The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller consists of two interdependent devices: portable controller (Cat. # SA10) and single patient use dissector (Cat. #s SASD14, SASD23, SASD36 and SASD45). The SA10 Portable Controller is a compact portable generator and provides power to drive the dissectors for dissection, coagulation, and cutting tissues in open or laparoscopic procedures.
The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller is intended to be used by qualified medical professionals trained in the techniques and surgical procedures, such as surgeons and nurses, in hospital operation rooms. SA10 Portable Controller is also intended to be maintained by trained service or biomedical engineers and validated for cleaning and disinfection between surgeries. The Advanced Dissector is integrated with a transducer for single use; therefore, no dissector-transducer assembly is required prior to surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller is intended to be used by qualified medical professionals trained in the techniques and surgical procedures, such as surgeons and nurses, in hospital operation rooms. SA10 Portable Controller is also intended to be maintained by trained service or biomedical engineers and validated for cleaning and disinfection between surgeries.
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:
- Cytotoxicity testing per ISO 10993-5 – Passed
- Sensitization testing per ISO 10993-10 – Passed
- Acute Systemic Toxicity Effects per ISO 10993-11 – Passed
- Intracutaneous Reactivity testing per ISO 10993-23 – Passed
- Pyrogen per USP – Passed
- Electrical Safety testing per IEC 60601-1 – Passed
- Electromagnetic Disturbance testing per IEC 60601-1-2 – Passed
- Electromagnetic Immunity testing per IEC 60601-4-2
- Software verification and validation per IEC 62304/FDA Guidance – results /conclusion
- Dimensional verification – Met specifications
- Sterilization validation – demonstrates SAL of 10-6
- Shelf-Life testing – Supports shelf life of 3 years
- Transportation testing per ASTM D4169 – Demonstrates package integrity maintained
- Ex Vivo Burst Pressure Study – Demonstrates the device can perform as intended
- Acute and Chronic Animal Study – Demonstrates the device can perform as intended in animal models
Clinical Performance Data:
No clinical data was necessary to determine the substantial equivalence of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K1312612, K101990
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 18, 2025
Shanghai Saints Sages Surgical Co., Ltd.
℅ Giselle Zhang
Lead QA&RA Consultant
Emergo Global Consulting, LLC
2500 Bee Cave Road
Building 1, Suite 300
Austin, Texas 78746
Re: K242894
Trade/Device Name: SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)
Regulatory Class: Unclassified
Product Code: LFL
Dated: May 16, 2025
Received: May 16, 2025
Dear Giselle Zhang:
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 (the 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 available 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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K242894 - Giselle Zhang
Page 2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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K242894 - Giselle Zhang
Page 3
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-devices/device-advice-comprehensive-regulatory-assistance/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,
James H. Jang -S (Digitally signed by James H. Jang -S Date: 2025.06.18 13:51:41 -04'00')
James Jang, 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242894
Device Name: SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)
Indications for Use (Describe)
SA10 Portable Controller is intended to provide power to drive SanAgile™ Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired.
SanAgile™ Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures.
The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
K242894 510(k) Summary
Shanghai Saints Sages Surgical Co., Ltd.
1. Submission Sponsor
Shanghai Saints Sages Surgical Co., Ltd.
No.19, Lane 388, Shengrong Road,
Pilot Free Trade Zone,
201210 Shanghai,
People's Republic of China
Xue Ting, RA Manager
Email: ting.xue@snssurgical.com.cn
Phone number: +86-13951232953
2. Submission Correspondent
Emergo by UL
2500 Bee Cave Road
Building 1, Suite 300
Austin, TX 78746
Office Phone: (512) 327-9997
Email: LST.US.EmergoFDASubmissions@ul.com or Giselle.Zhang@ul.com
Contact: Giselle.Zhang@ul.com
Title: Lead QA&RA Consultant
3. Date Prepared
06/18/2025
4. Device Identification
Trade/Proprietary Name: SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller
Classification Name: Instrument, Ultrasonic Surgical
Regulation Number(s): Pre-Amendment
Product Code(s): LFL
Class: Unclassified
Classification Panel: General & Plastic Surgery
Page 6
5. Legally Marketed Predicate Device(s)
Device name: HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length)
510(k) number: K1312612
Manufacturer: ETHICON ENDO-SURGERY, LLC
Device name: Ethicon Endo-Surgery Generator GIlI
510(k) number: K101990
Manufacturer: ETHICON ENDO-SURGERY, LLC
6. Indication for Use Statement
SA10 Portable Controller is intended to provide power to drive SanAgile™ Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired.
SanAgile™ Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures.
The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button.
7. Device Description
The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller consists of two interdependent devices: portable controller (Cat. # SA10) and single patient use dissector (Cat. #s SASD14, SASD23, SASD36 and SASD45). The SA10 Portable Controller is a compact portable generator and provides power to drive the dissectors for dissection, coagulation, and cutting tissues in open or laparoscopic procedures.
The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller is intended to be used by qualified medical professionals trained in the techniques and surgical procedures, such as surgeons and nurses, in hospital operation rooms. SA10 Portable Controller is also intended to be maintained by trained service or biomedical engineers and validated for cleaning and disinfection between surgeries. The Advanced Dissector is integrated with a transducer for single use; therefore, no dissector-transducer assembly is required prior to surgery.
8. Substantial Equivalence Discussion
The following table compares the SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of
Page 7
substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.
Comparison of Characteristics
Page 8
Portable Controller
| Attribute | Subject: SanAgileTM Ultrasonic Surgery Advanced Dissector and Portable Controller | Predicate: Ethicon Endo-Surgery Generator GIlI K101990 | Comparison Comments |
|---|---|---|---|
| Device Classification | Same | Class II | N/A |
| Product Code | Same | LFL, GEI, HGI | N/A |
| Regulation Number | Same | N/A | N/A |
| Indications for Use | SA10 Portable Controller is intended to provide power to drive SanAgileTM Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired. SanAgileTM Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures. The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button. | The Generator G11 provides radiofrequency power to drive EnSeal® electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissue. In addition the generator provides power to drive Harmonic® ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. EnSeal® and Harmonic® instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures. | Different |
| Technology | Ultrasonic energy | Ultrasonic energy, Adaptive Tissue Technology | Different |
| Output (Maximum Electrical Power) | Same | 35W | N/A |
| Power Setting | Two energy delivery buttons Minimum and maximum button. User cannot adjust | Three energy delivery buttons: • MAX Hand Control Button (both sides of instrument) • MIN Hand Control Button (both sides of instrument) • Advanced Hemostasis Hand Control Button | Different |
Page 9
Dissector
| Attribute | Subject: SanAgileTM Ultrasonic Surgery Advanced Dissector and Portable Controller | Predicate: HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length) K132612 | Comparison Comments |
|---|---|---|---|
| Device Classification | Same | Unclassified | N/A |
| Product Code | Same | LFL | N/A |
| Regulation Number | Same | N/A | N/A |
| Indications for Use | SA10 Portable Controller is intended to provide power to drive SanAgileTM Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired. SanAgileTM Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures. The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button. | The HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button. | Different |
| Technology | Ultrasonic energy | Ultrasonic energy, Adaptive Tissue Technology | Different |
| Sterility | Same | EO Sterilized | N/A |
| Output (Drive Frequency) | Same | 55.5 kHz | N/A |
| Shaft Diameter | 5mm | 5 mm | Different |
| Jaw Aperture | 11.23 mm | 11.16 mm | N/A |
| Jaw Length | 17 mm | 14.56 mm | N/A |
| Clamping Force | Same | 13.30N | N/A |
| Grasping Force | > 10N | 11.50N | N/A |
| Blade Design / Geometry | Same | Curved | N/A |
Page 10
| Attribute | Subject: SanAgileTM Ultrasonic Surgery Advanced Dissector and Portable Controller | Predicate: HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length) K132612 | Comparison Comments |
|---|---|---|---|
| Shaft Lengths | 14, 23, 36, 45 cm | 23, 36, 45 cm | Different |
| Packaging | Same | ASTM D4196 ISO 11607-1 | N/A |
| Energy Activation Method | Hand-switches | Hand-switches and footswitches | Different |
| Maximum Indicated Vessel Size | Same | 7mm | N/A |
| Handle Type | Same | Pistol Grip | N/A |
| Electrical Safety | Same | IEC 60601-1 | N/A |
| EMC | Same | IEC 60601-1-2 | N/A |
| Biocompatibility | Same | Biocompatible | N/A |
Page 11
9. Non-Clinical Performance Data
To demonstrate safety and effectiveness of SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller and to show substantial equivalence to the predicate device, Saint Sages completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The SanAgile™Ultrasonic Surgery Advanced Dissector and Portable Controller passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:
- Cytotoxicity testing per ISO 10993-5 – Passed
- Sensitization testing per ISO 10993-10 – Passed
- Acute Systemic Toxicity Effects per ISO 10993-11 – Passed
- Intracutaneous Reactivity testing per ISO 10993-23 – Passed
- Pyrogen per USP – Passed
- Electrical Safety testing per IEC 60601-1 – Passed
- Electromagnetic Disturbance testing per IEC 60601-1-2 – Passed
- Electromagnetic Immunity testing per IEC 60601-4-2
- Software verification and validation per IEC 62304/FDA Guidance – results /conclusion
- Dimensional verification – Met specifications
- Sterilization validation – demonstrates SAL of 10-6
- Shelf-Life testing – Supports shelf life of 3 years
- Transportation testing per ASTM D4169 – Demonstrates package integrity maintained
- Ex Vivo Burst Pressure Study – Demonstrates the device can perform as intended
- Acute and Chronic Animal Study – Demonstrates the device can perform as intended in animal models
10. Clinical Performance Data
No clinical data was necessary to determine the substantial equivalence of this device.
11. Statement of Substantial Equivalence
The SanAgile™Ultrasonic Surgery Advanced Dissector and Portable Controller has the same intended use as the predicate device and similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Based on the results of the risk assessment and all applicable testing, the SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller is determined to perform as intended during normal anticipated usage and is at least as safe, as effective, and performs as well as the legally marketed predicate device and therefore is substantially equivalent to the predicate device.