(118 days)
No
The description mentions "Adaptive Tissue Technology" which modulates power output based on tissue identification, but this is described as a function of the generator monitoring the instrument, not explicitly using AI/ML for learning or complex pattern recognition. The performance studies focus on standard engineering and biological tests, not AI/ML model validation.
Yes
The device is indicated for soft tissue incisions, bleeding control, and other open and endoscopic procedures, which directly align with therapeutic applications.
No
The device is described as surgical shears used for cutting, coagulation, and dissection of tissue. Its intended uses involve performing medical procedures (incisions, sealing vessels) rather than diagnosing conditions or identifying diseases.
No
The device description clearly outlines a physical instrument with a handle, handpiece, buttons, shaft, clamp arm, and blade. The performance studies focus on physical and electrical characteristics, not software validation.
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," "bleeding control," "minimal thermal injury," and "coagulation of veins and arteries" during surgical procedures. These are all actions performed directly on the patient's body during surgery.
- Device Description: The device description details a surgical instrument with a handle, handpiece, energy delivery buttons, blade, and clamp arm. These are components of a surgical tool used for cutting, grasping, and sealing tissue.
- Lack of IVD Characteristics: An In Vitro Diagnostic device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with patient specimens or analysis performed outside the body.
The device is clearly a surgical instrument used for therapeutic and procedural purposes in vivo (within the living body), not for diagnostic testing in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The Reprocessed HARMONIC 1100 Shears 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, pediatric, gynecologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of veins up to and including 5 mm in diameter and arteries up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.
Product codes
NLQ
Device Description
The Reprocessed HARMONIC 1100 Shears sterile instruments are used for dissection, grasping, coaqulation, and cutting between the blade and clamp arm. Each device model consists of an ergonomic handle, an integrated hand piece, and two energy delivery buttons:
- Energy Button - User can adjust power levels from 1-5
- . Energy button with Advanced Hemostasis – For larger vessel sealing; user cannot adjust.
The instruments are available in two shaft lengths, 20 cm and 36 cm. An integrated audible and tactile mechanism in the handle indicates full trigger closure. The instrument has a clamp arm and coated curved blade that are deigned to work through a 5 mm trocar, through a 5mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated continuously to facilitate visualization and access to targeted tissue. The two dashes on the instrument are intended to represent relative vessel size. The energy button is indicated for vessels up to 5 mm in diameter. When the energy button is used, cutting speed is the fastest. The energy button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy button with Advanced Hemostasis in used, cutting speed in reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, lymphatic vessels
Indicated Patient Age Range
pediatric
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed HARMONIC 1100 Shears. This included the following tests:
- Biocompatibility
- Validation of Reprocessing
- Sterilization
- Electrical Safety and Electromagnetic Compatibility
- Functional Performance Tests
Blade to Clamp Arm Angle
Actuating Trigger Force
Energy Button Activation Force
Advanced Hemostasis (AH) Button Activation Force
Rotation Knob Force
Jaw Clamp Force
Tissue Retention Force
Leak Test
Bend Test
ATT Functionality and Transection Time
Burst Pressure
Maximum Jaw and Shaft Temperature
Reliability Cycling
Burst Pressure (Post-Reliability)
Maximum Jaw and Shaft Temperature (Post-Reliability)
Performance Attribute Testing
The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2, and verification/comparative testing (to the predicate device).
Additionally, preclinical laboratory evaluations in an animal model were performed, which included acute and chronic survival studies. The studies were done to evaluate thermal spread and the ability to achieve hemostasis of vessels of the reprocessed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HARMONIC 1100 Shears 20cm Length; HARMONIC 1100 Shears 36cm Length (K200841)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 20, 2024
Stryker Sustainability Solutions Aphrodeja Crutch Staff Specialist, Regulatory Affairs 1810 Drake Dr. Tempe, Arizona 85283
Re: K233471
Trade/Device Name: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) Regulation Number: 21 CFR Unclassified Regulation Name: Regulatory Class: Class II Product Code: NLQ Dated: October 23, 2023 Received: October 25, 2023
Dear Aphrodeja Crutch:
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 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"
1
(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 OS 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 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-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 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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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. Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.02.20 14:09:02 -05'00' Mark Trumbore, Ph.D. 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
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Enclosure:
Models For This Submission
Description: Reprocessed HARMONIC 1100 Shears Model Numbers: HAR1120 and HAR1136
Physical Description/Specifications
The Reprocessed HARMONIC 1100 Shears sterile instruments are used for dissection, grasping, coaqulation, and cutting between the blade and clamp arm. Each device model consists of an ergonomic handle, an integrated hand piece, and two energy delivery buttons:
- Energy Button - User can adjust power levels from 1-5
- . Energy button with Advanced Hemostasis – For larger vessel sealing; user cannot adjust.
The instruments are available in two shaft lengths, 20 cm and 36 cm. An integrated audible and tactile mechanism in the handle indicates full trigger closure. The instrument has a clamp arm and coated curved blade that are deigned to work through a 5 mm trocar, through a 5mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated continuously to facilitate visualization and access to targeted tissue. The two dashes on the instrument are intended to represent relative vessel size. The energy button is indicated for vessels up to 5 mm in diameter. When the energy button is used, cutting speed is the fastest. The energy button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy button with Advanced Hemostasis in used, cutting speed in reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate.
3
Indications for Use
510(k) Number (if known) K233471
Device Name
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136)
Indications for Use (Describe)
The Reprocessed HARMONIC 1100 Shears 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, pediatric, gynecologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of veins up to and including 5 mm in diameter and arteries 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
| Applicant Name: | Stryker Sustainability Solutions |
|---|---|
| Contact Person: | Aphrodeja Crutch |
| Staff Specialist | |
| 1810 Drake Drive | |
| Tempe, AZ 85283 | |
| Phone: 404-993-1981 | |
| Email: Aphrodeja.Crutch@stryker.com | |
| Device Trade Name: | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm |
| Length (HAR1120); Reprocessed HARMONIC 1100 Shears, | |
| 5mm Diameter, 36cm Length (HAR1136) | |
| Common Name: | Instrument, Ultrasonic Surgical |
| Classification Name: | Instrument, Ultrasonic Surgical |
| Regulation Number: | Unclassified |
| Product Code: | NLO |
| Device Class: | Class II |
| Date Prepared: | 02/20/2024 |
| Predicate Device: | HARMONIC 1100 Shears 20cm Length; HARMONIC 1100 |
| Shears 36cm Length (K200841) | |
| Predicate Product Code: | LFL |
| Description | The Reprocessed HARMONIC 1100 Shears instrument is a |
| sterile, single patient use instrument used for dissection, | |
| grasping, coagulation, and cutting between the blade and | |
| clamp arm. It consists of an ergonomic handle with an | |
| integrated hand piece and two energy delivery buttons. |
-
Energy button for power levels 1-5, and
-
Energy with Advanced Hemostasis button for large vessel
sealing.
The instrument is available in two shaft lengths (20 cm and 36
cm). An integrated audible and tactile mechanism in the grip
housing indicates full trigger closure. The instrument has a
clamp arm and coated curved blade that are 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 instrument shafts can be rotated continuously
to facilitate visualization and access to targeted tissue. The
two dashes on the instrument are intended to represent
relative vessel size. The Energy button is indicated for vessels
up to 5mm in diameter. When the Energy button is used,
cutting speed is the fastest. The energy button with Advanced
Hemostasis is designed for larger vessels and is indicated for
veins up to and including 5 mm in diameter and arteries up to
and including 7 mm in diameter. When the Energy button
with Advanced Hemostasis is used, cutting speed is reduced
and hemostasis is maximized. The instrument utilizes
Adaptive Tissue Technology. This provides the generator with
the ability to identify and monitor the instrument during use,
which enables the generator to modulate and adjust its power
output as well as provide audible feedback to the user as
appropriate. The HARMONIC 1100 Shears instrument is
designed for use exclusively with the Generator 11 (GEN11)
software version 2018-1 or later. |
| Indications for Use: | The Reprocessed HARMONIC 1100 Shears 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, pediatric, gynecologic, urologic, thoracic,
sealing and transection of lymphatic vessels, and other open
and endoscopic procedures. The instruments allow for the
coagulation of veins up to and including 5 mm in diameter
and arteries up to and including 7 mm in diameter, using the
Energy button with Advanced Hemostasis. |
| Summary of Intended Use and
Technologies: | The design, materials, and intended use of the Reprocessed
HARMONIC 1100 Shears are equivalent to the predicate
device. The mechanism of action of the reprocessed device is
identical to the predicate device in that the same standard
mechanical design, materials, and size is utilized. There are no
changes to the claims, intended use, clinical application,
patient population, performance specifications, or method of
operation. In addition, Stryker Sustainability Solutions'
reprocessing of the device includes removal of adherent
visible soil and decontamination. Each individual device is
tested for appropriate function of its components prior to
packaging and labeling operations. The only differences
between the Reprocessed HARMONIC 1100 Shears and the
predicate HARMONIC 1100 Shears are that the device is
reprocessed, and some device components are replaced with
equivalent components during the reprocessing operation. |
| Non-Clinical Testing: | Bench and laboratory testing was conducted to demonstrate
performance (safety and effectiveness) of the Reprocessed
HARMONIC 1100 Shears. This included the following tests: |
| | • Biocompatibility
• Validation of Reprocessing
• Sterilization
• Electrical Safety and Electromagnetic Compatibility
• Functional Performance Tests
Blade to Clamp Arm Angle
Actuating Trigger Force
Energy Button Activation Force
Advanced Hemostasis (AH) Button Activation Force
Rotation Knob Force
Jaw Clamp Force
Tissue Retention Force
Leak Test
Bend Test
ATT Functionality and Transection Time
Burst Pressure
Maximum Jaw and Shaft Temperature
Reliability Cycling
Burst Pressure (Post-Reliability)
Maximum Jaw and Shaft Temperature (Post-Reliability)
Performance Attribute Testing |
| | The functional performance testing involved electrical safety
and electromagnetic compatibility testing in accordance with
IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2, and
verification/comparative testing (to the predicate device). |
| | Additionally, preclinical laboratory evaluations in an animal
model were performed, which included acute and chronic
survival studies. The studies were done to evaluate thermal
spread and the ability to achieve hemostasis of vessels of the
reprocessed device. |
| Clinical Testing: | Clinical testing was not required for this submission. |
| Conclusion: | The subject device Reprocessed HARMONIC 1100 Shears,
5mm Diameter, 20cm Length (HAR1120); Reprocessed
HARMONIC 1100 Shears, 5mm Diameter, 36 cm Length
(HAR1136) is substantially equivalent to the previously
cleared predicate device HARMONIC 1100 Shears 20cm
Length; HARMONIC 1100 Shears 36cm Length (K200841). |
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