(236 days)
No
The summary describes a reprocessed surgical instrument that uses ultrasonic energy for tissue cutting and coagulation. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for soft tissue incisions and coagulation of vessels, which are actions intended to treat or alleviate a medical condition.
No
The device is indicated for soft tissue incisions, coagulation, and mechanical transection, which are therapeutic and surgical functions, not diagnostic.
No
The device description clearly indicates a physical, hand-actuated instrument used for surgical procedures, involving mechanical transection and energy delivery. This is a hardware device, 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 describes the device as being used for soft tissue incisions, coagulation of vessels, and mechanical transection of soft tissue during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The device description details a surgical instrument used for grasping, coagulating, and transecting tissue.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health, diagnosis, or condition.
IVD devices are specifically designed to be used in vitro (in glass, or outside the body) to analyze biological samples. This device is clearly used in vivo (in the living body) during surgery.
N/A
Intended Use / Indications for Use
The Sterilmed Reprocessed HARMONIC ACE®+ 7 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
NLQ
Device Description
The Sterilmed Reprocessed HARMONIC ACE+7 Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The two models are identical to each other in materials, form, fit and function except for the length of the shafts which are 23cm and 36 cm.
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
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)
Specific non-clinical tests performed included: cleaning validation, sterilization verification, ethylene oxide residual testing (ISO 10993-7), packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and shelf-life validation (ASTM 1980-07). In addition, validation of functional performance (bench testing) was performed through simulated use, visual inspection, and fatigue testing. Testing performed: Electrical Safety Vein Seal Burst (1-7mm) and Tissue Adhesion Artery Seal Burst (1-7mm) and Tissue Adhesion Lymphatics Seal Performance Vessel Seal Thermal Spread Drop Fluid Ingress Pad Retention Pad Life Grasping Force Performance testing shows the Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis performs as originally intended. In addition, the device was tested for biocompatibility per ISO 10993-1 for external communicating device, short duration contact with circulating blood (
N/A
0
Indications for Use
510(k) Number (if known)
Device Name
Sterilmed Reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis (Models HARH23R and HARH36R)
Indications for Use (Describe)
The Sterilmed Reprocessed HARMONIC ACE®+ 7 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, 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.
| 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) |
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1
| Ethicon OEM
Model # | Sterilmed
Model # | Description |
|------------------------|----------------------|------------------------------------------------------------------------------|
| HARH23 | HARH23R | Reprocessed HARMONIC ACE+ 7 Shears with
Advanced Hemostasis, 23 cm Length |
| HARH36 | HARH36R | Reprocessed HARMONIC ACE+ 7 Shears with
Advanced Hemostasis, 36 cm Length |
2
Image /page/2/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Below the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 15, 2019
Sterilmed. Inc. Ms. Jan Flegeau, B.A. Associate Director, Regulatory Affairs 5010 Cheshire Parkway N. Suite 2 Plymouth, Minnesota 55446
Re: K182272
Trade/Device Name: Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis (Models HARH23R and HARH36R) Regulatory Class: Unclassified Product Code: NLQ
Dated: March 14, 2019 Received: March 15, 2019
Dear Ms. Flegeau:
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
3
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
| Date Prepared: | April 11, 2019 |
|---|---|
| Submitter and | |
| Manufacturer: | Sterilmed, Inc. |
| 5010 Cheshire Parkway N, Suite 2 | |
| Plymouth, MN 55446 | |
| www.sterilmed.com | |
| Manufacturing | |
| Facility Address: | 11400 73rd Avenue |
| North Maple Grove | |
| MN 55369 | |
| Official | |
| Correspondent: | Ms. Jan Flegeau, B.A. |
| Associate Director, Regulatory Affairs | |
| Sterilmed, Inc. | |
| Tel: 786-575-5903 | |
| Email: jflegeau@its.jnj.com | |
| Trade Name: | Reprocessed HARMONIC ACE®+ 7 Shears with Advanced |
| Hemostasis (Models HARH23R and HARH36R) | |
| Regulation Name: | Scalpel, Ultrasonic, Reprocessed |
| Device Classification: | Unclassified |
| Product Code | NLQ |
| Predicate Device: | HARMONIC ACE®+7 Shears with Advanced Hemostasis |
| (Ethicon K132612 - Models HARH23 and HARH36) | |
| Device Description: | The Sterilmed Reprocessed HARMONIC ACE+7 Shears with |
| Advanced Hemostasis are used for coagulation and mechanical | |
| transection of soft tissue during laparoscopic and open | |
| procedures. The devices allow the surgeon to grasp, coagulate, | |
| and transect soft tissue with a single instrument. The devices | |
| are hand-actuated with a shaft and tissue effector that can be | |
| rotated. The energy delivery can be activated with hand | |
| activation or with an optional generator foot switch. | |
| The two models are identical to each other in materials, form, | |
| fit and function except for the length of the shafts which are | |
| 23cm and 36 cm. | |
| Model Numbers | HARH23R (shaft length 23 cm) |
| HARH36R (shaft length 36 cm) | |
| Indications For Use: | The Sterilmed Reprocessed HARMONIC ACE+ 7 Shears with |
| Advanced Hemostasis are indicated for soft tissue incisions | |
| when bleeding control and minimal thermal injury are desired. | |
| 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. | |
| Technological | |
| Characteristics: | The Reprocessed HARMONIC ACE+ 7 Shears with Advanced |
| Hemostasis has the same technological and performance | |
| characteristics as the predicate device HARMONIC ACE+ 7 | |
| Shears with Advanced Hemostasis (K132612). The subject | |
| devices use an EEPROM memory chip that stores device | |
| identification, usage tracking, and operating parameters for use | |
| by the Generator G11 that provides power for the Reprocessed | |
| HARMONIC ACE+ 7 Shears with Advanced Hemostasis. The | |
| devices have an ergonomic grip housing assembly with hand | |
| control buttons (MIN for minimum power level, MAX for | |
| maximum power level, and Advanced Hemostasis for large | |
| vessel [up to 7 mm] sealing). | |
| Adaptive Tissue Technology refers to the power output | |
| algorithm that is utilized by the devices. During use, the | |
| Adaptive Tissue Technology algorithm parameters stored on | |
| the device EEPROM are read by the generator and used to | |
| reduce the power (current) to the instrument and provide a | |
| secondary, higher pitched generator activation tone as | |
| Adaptive Tissue Technology regulates the delivery of energy. | |
| To do this the generator monitors the thermal condition of the | |
| blade during device activation. The Advanced Hemostasis | |
| mode utilizes a unique algorithm within Adaptive Tissue | |
| Technology that modulates the power delivery from the | |
| Generator G11 to the blade of the device maximizing | |
| hemostasis. | |
| Functional and Safety | |
| Testing: | Representative samples of reprocessed devices were tested to |
| demonstrate appropriate functional characteristics. Process | |
| validation testing was performed to validate cleaning and | |
| sterilization as well as device packaging. In addition, the | |
| manufacturing process includes visual and validated functional | |
| testing of all products produced. Where appropriate, prior | |
| validation testing of previously cleared Reprocessed | |
| HARMONIC Shears: ACE- (K132566) or Reprocessed | |
| HARMONIC Shears: ACE + (K161086) was utilized as the | |
| devices are substantially equivalent. The Reprocessed | |
| HARMONIC Shears with Advanced Hemostasis: ACE + 7, are | |
| reprocessed no more than one (1) time. The torque wrench | |
| accessories are reprocessed no more than five (5) times. Each | |
| device and accessory are marked and tracked through the | |
| reprocessing cycle. After the device or torque wrench has | |
| reached the maximum number of reprocessing cycles, one and | |
| five, respectively, it is rejected from further reprocessing. | |
| Summary of | |
| Non-Clinical Tests | |
| Conducted: | Specific non-clinical tests performed included: cleaning |
| validation, sterilization verification, ethylene oxide residual | |
| testing (ISO 10993-7), packaging validation (ASTM D4169, | |
| ASTM F88, ASTM F2096), and shelf-life validation (ASTM | |
| 1980-07). In addition, validation of functional performance | |
| (bench testing) was performed through simulated use, visual | |
| inspection, and fatigue testing. Testing performed: | |
| Electrical Safety Vein Seal Burst (1-7mm) and Tissue Adhesion Artery Seal Burst (1-7mm) and Tissue Adhesion Lymphatics Seal Performance Vessel Seal Thermal Spread Drop Fluid Ingress Pad Retention Pad Life Grasping Force Performance testing shows the Reprocessed | |
| HARMONIC ACE+ 7 Shears with Advanced | |
| Hemostasis performs as originally intended. | |
| In addition, the device was tested for biocompatibility | |
| per ISO 10993-1 for external communicating device, | |
| short duration contact with circulating blood ( |