(103 days)
The Harmonic HD 1000i Shears instrument is 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, 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 Energy button with Advanced Hemostasis.
The HARMONIC HD 1000i Shears are a sterile, single patient use device used for dissection, grasping, coagulation, and cutting between the blade and clamp arm. It consists of an ergonomic grip housing assembly with two hand control buttons: 1) Energy button for power levels 1-5 and, 2) Energy with Advanced Hemostasis button for large vessel sealing. The device is available in two shaft lengths, 20 cm and 36 cm, and both device shafts can be rotated continuously to facilitate visualization and access to targeted tissue. An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The device has a clamp arm and coated curved blade that is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The blade used in the HARMONIC HD 1000i Shears has a slightly different blade design than that of the predicate device, the HARMONIC ACE+Shears with Advanced Hemostasis (cleared under K132612 on October 17, 2013), and is also slightly longer and more tapered than the predicate device. Additionally, two dashes have been added to the device which are intended to represent relative vessel size. The distal/front Energy button is indicated for vessels up to 5 mm in diameter. The Energy with Advanced Hemostasis button (the Green button), which is found on the side of the device handle, is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. The device utilizes Adaptive Tissue Technology (the technological characteristics of which were first cleared under K120729 on May 17, 2012). This technology provides the generator with the ability to identify and monitor the instrument during use. The HARMONIC HD 1000i Shears are designed for use exclusively with the Ethicon Generator 11 (GEN11).
The provided text describes the HARMONIC HD 1000i Shears. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance & Adjudication method
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes various tests performed and states that the "Data generated from the bench testing met the predetermined acceptance criteria" and that "the results of the acute/survival studies demonstrated that the tissue effects were not different than the predicate device."
Here's an attempt to structure the information into a table format based on the descriptions:
| Test / Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance | Adjudication Method |
|---|---|---|---|
| Sterilization | Sterilized to the same sterility assurance level as the predicate device. | Both the subject and predicate devices are sterilized via ethylene oxide and to the same sterility assurance level. | Not explicitly stated, but implicitly a pass/fail against established sterility assurance level. |
| Biocompatibility | No new materials introduced, therefore no new biocompatibility concerns. | Biocompatibility testing was not required as no new materials were introduced. | Not applicable (no test performed). |
| Electrical Safety | Compliance with IEC 60601-1:2005. | The system was shown to comply with IEC 60601-1:2005 for electrical safety. | Not explicitly stated, but typically involves objective measurement against standard thresholds. |
| EMC | Compliance with IEC 60601-1-2:2007. | The system was shown to comply with IEC 60601-1-2:2007 for electromagnetic compatibility. | Not explicitly stated, but typically involves objective measurement against standard thresholds. |
| Bench Testing | Predetermined acceptance criteria (specific values not provided in text). | Data generated from the bench testing (tissue pad life, tissue pad removal force, instrument grasping force, sealed vessel burst test) met the predetermined acceptance criteria. | Not explicitly stated, but implies a comparison against pre-defined numerical limits or ranges for each metric. |
| Acute Animal Testing | Tissue effects not different from the predicate device (for hemostatic transection, lateral thermal damage, tissue dissection, back cutting). | The results of the acute studies demonstrated that the tissue effects were not different than the predicate device for hemostatic transection of vessel pedicles (< 5mm using Energy button, ≤ 7mm using Advanced Hemostasis button), lateral thermal damage, tissue dissection, and back cutting on a porcine model. | Comparison with predicate device, likely involving expert observation and measurement of tissue effects (e.g., thermal spread, completeness of transection, hemostasis). The standard is "not different," implying qualitative and quantitative comparison. |
| Survival Animal Testing | Tissue effects not different from the predicate device (for hemostatic transection, healed vessel seals under blood pressure challenge). | The results of the survival studies demonstrated that the tissue effects were not different than the predicate device for hemostatic transection of vessel pedicles (≤ 5mm using Energy button, ≤ 7mm using Advanced Hemostasis button) in splenectomy and carotid artery procedures, and in blood pressure challenge for healed vessel seals. | Comparison with predicate device, likely involving expert observation during necropsy and analysis of tissue samples, including evaluation of healed vessel seals under stress. The standard is "not different." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for bench tests. For animal studies, the document mentions "an acute porcine study" and "a chronic survival study" without specifying the number of animals or specific data points.
- Data Provenance: The animal studies were conducted using a porcine (pig) model. The country of origin of the data is not specified, but the submission is to the FDA in the USA. The studies are prospective in nature, as they involve performing new tests to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts or their qualifications. However, for animal studies, evaluation of tissue effects and necropsy would typically involve veterinary pathologists or surgeons with expertise in animal physiology and surgical pathology.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly described as a formal process like "2+1" or "3+1." The determination of "not different than the predicate device" in animal studies implies expert judgment and comparison, likely by the researchers conducting the study. For bench testing, it would involve confirming measurements against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is a medical device (surgical shears) and not an imaging or diagnostic AI device that would typically involve multiple readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The HARMONIC HD 1000i Shears are a surgical instrument requiring human operation, not a standalone algorithm.
7. Type of Ground Truth Used
The ground truth for the performance evaluations (especially animal studies) appears to be:
- Expert Observation/Assessment: Direct observation and assessment of tissue effects (hemostasis, thermal damage, completeness of transection) by qualified personnel during and after surgical procedures.
- Pathology/Histology: Implied for detailed assessment of tissue damage and healing in animal studies (though not explicitly called out as "pathology," it's the standard for evaluating tissue effects).
- Objective Measurements: For bench tests (e.g., burst pressure, grasping force).
8. Sample Size for the Training Set
Not applicable. This device is a mechanical surgical instrument, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2016
Ethicon Endo-Surgery, LLC % Mr. David Locke Senior Regulatory Affairs Program Lead Ethicon Endo-surgery, LLC 475 Calle C Guaynabo, PR 00969
Re: K160752
Trade/Device Name: Harmonic HD 1000i Shears 20 cm Length, Harmonic HD 1000i Shears 36 cm Length Regulatory Class: Unclassified Product Code: LFL Dated: May 20, 2016 Received: May 23, 2016
Dear Mr. Locke:
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 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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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 yours,
Jennifer R. Stevenson -A
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
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Indications for Use
510(k) Number (if known) K160752
Device Name
HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
Indications for Use (Describe)
The Harmonic HD 1000i Shears instrument is 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, 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 Energy button with Advanced Hemostasis.
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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510(k) Summary
| Company | Ethicon Endo-Surgery, LLC |
|---|---|
| 475 Calle C | |
| Guaynabo, PR 00969 |
David Locke, DRSc, MS, RAC Contact Senior Regulatory Affairs Program Lead Ethicon Endo-Surgery, Inc. Telephone: (513) 337-1281 Email: dlocke1(@its.jnj.com
Date Prepared
June 27, 2016
Device Name
Trade Name: HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
Common Name: Instrument, Ultrasonic Surgical
Classification Name
Instrument, Ultrasonic Surgical (Unassigned, Product Code: LFL)
Regulatory Class
Unclassified
Predicate Device
HARMONIC ACE + Shears with Advanced Hemostasis, cleared under K132612 on October 17th, 2013
Device Description
The HARMONIC HD 1000i Shears are a sterile, single patient use device used for dissection, grasping, coagulation, and cutting between the blade and clamp arm. It consists of an ergonomic grip housing assembly with two hand control buttons: 1) Energy button for power levels 1-5 and, 2) Energy with Advanced Hemostasis button for large vessel sealing. The device is available in two shaft lengths, 20 cm and 36 cm, and both device shafts can be rotated continuously to facilitate visualization and access to targeted tissue.
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An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The device has a clamp arm and coated curved blade that is designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The blade used in the HARMONIC HD 1000i Shears has a slightly different blade design than that of the predicate device, the HARMONIC ACE+Shears with Advanced Hemostasis (cleared under K132612 on October 17, 2013), and is also slightly longer and more tapered than the predicate device. Additionally, two dashes have been added to the device which are intended to represent relative vessel size.
The distal/front Energy button is indicated for vessels up to 5 mm in diameter. The Energy with Advanced Hemostasis button (the Green button), which is found on the side of the device handle, is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. The device utilizes Adaptive Tissue Technology (the technological characteristics of which were first cleared under K120729 on May 17, 2012). This technology provides the generator with the ability to identify and monitor the instrument during use.
The HARMONIC HD 1000i Shears are designed for use exclusively with the Ethicon Generator 11 (GEN11).
Indications for Use
Indications
The Harmonic HD 1000i Shears instrument is 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 Energy button with Advanced Hemostasis. Contraindications
- · The instruments are not indicated for incising bone.
- The instruments are not intended for contraceptive tubal occlusion.
Technological Characteristics
The Ethicon Endo-Surgery HARMONIC HD 1000i Shears incorporate the same technological characteristics as that of the ultrasonic predicate device, HARMONIC ACE+ Shears with Advanced Hemostasis. Both the subject and predicate 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 HARMONIC HD 1000i Shears. Further, both devices have an ergonomic grip housing assembly which allows for manual closure of the jaw and the devices contain buttons which allow for the manual application of energy. To as where the predicate HARMONIC ACE+ Shears with Advanced Hemostasis contains three buttons allowing for manual energy activation, the subject HARMONIC HD 1000i Shear only contains two buttons, allowing for manual energy activation.
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Performance Data
Bench testing and laboratory evaluations in an animal model including acute and 30-day chronic survival studies were conducted to demonstrate that the HARMONIC HD 1000i performs as intended.
Sterilization
Both the subject and predicate devices are sterilized via ethylene oxide and both devices are sterilized to the same sterility assurance level.
Biocompatibility Testing
Biocompatibility testing was not required for this submission as no new materials were introduced on this device.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the HARMONIC HD 1000i device. The system was shown to comply with IEC 60601-1-2:2007 for electromagnetic compatibility and IEC 60601-1:2005 for electrical safety.
Bench Testing
Tissue pad life, tissue pad removal force, instrument grasping force and sealed vessel burst test were evaluated for HARMONIC HD 1000i device to support substantial equivalence to the predicate device. Data generated from the bench testing met the predetermined acceptance criteria.
Acute Animal Testing
Testing was performed in an acute porcine study with the HARMONIC HD 1000i device vs. the predicate device to demonstrate that the tissue effects were not different than the predicate device. Evaluations included hemostatic transection of vessel pedicals < 5 mm using the Energy button and ≤ 7 mm in diameter using the Energy button with Advanced Hemostasis. Additional head-to-head testing included lateral thermal damage, tissue dissection, and back cutting on the porcine model. The results of the acute studies demonstrated that the tissue effects were not different than the predicate device.
Survival Animal Testing
Testing was performed in a chronic survival study with the HARMONIC HD 1000i device vs. the predicate device to demonstrate that the tissue effects were not different than the predicate device. Evaluations included hemostatic transection of vessel pedicals ≤ 5 mm using the Energy button and ≤ 7 mm in diameter using the Energy button with Advanced Hemostasis in splenectomy and carotid artery procedures. The chronic survival studies included a blood pressure challenge immediately prior to necropsy as an overstress test of the healed vessel seals.
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K160752
The results of the survival studies demonstrated that the tissue effects were not different than the predicate device.
Clinical Studies
This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.
Conclusion
The results of the bench testing and laboratory evaluations in an animal model demonstrate that the HARMONIC HD 1000i device is as safe and effective and performs as well as the identified legally marketed predicate devices for cutting, coagulating and dissecting soft tissue and sealing vessels up to 7 mm in diameter.
N/A