(350 days)
No
The description focuses on the mechanical and electrical properties of surgical instruments and does not mention any AI/ML components or functionalities.
No
The device is a set of surgical instruments used for cutting, manipulating, grasping, clamping, dissecting, or suction during surgical procedures, which are tools for performing therapy rather than providing therapy themselves.
No
The device description clearly states its intended uses are for "cutting, manipulating, grasping, clamping, dissecting, or suction" during surgical procedures, which are interventional actions, not diagnostic ones.
No
The device description clearly states the instruments are made from Stainless Steel and PEEK, indicating they are physical hardware devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (open or thoracoscopic) involving cutting, manipulating, grasping, clamping, dissecting, or suction. This describes a surgical instrument used on the patient's body, not a device used to examine specimens from the body to diagnose or monitor a condition.
- Device Description: The description details a surgical instrument made of stainless steel and PEEK, designed for physical manipulation during surgery. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening.
- Reagents, calibrators, or controls.
The device is clearly a surgical instrument used directly in a surgical procedure.
N/A
Intended Use / Indications for Use
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are intended for use in open or thoracoscopic surgical procedures. They are designed for cutting, manipulating, grasping, clamping, dissecting or suction.
Product codes
GCJ
Device Description
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are designed for cutting, manipulating, grasping, clamping, dissecting, or suction during open, or thoracoscopic surgical procedures. The instruments are reusable and are made from Stainless Steel with monopolar capabilities. The instruments are modular, consisting of a jaw insert and insulated outer tube with interchangeable ratcheting and non-ratcheting handles. The instruments are 250mm in length with a 7mm diameter.
The instruments can be used interchangeably with either a ratcheting or non-ratcheting handle. The handles are made from PEEK with a HF connection that fits any standard monopolar cable.
The instruments can be used with a visualization system to allow for better visibility during the procedure. This is an independent system and is not system specific. No new visualization systems are being introduced by Aesculap® in this submission.
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
The following design verification testing was completed for the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments:
- Blocking function: Demonstrates single actuating element allows for temporary actuation of the barrier and latching and unlocking of the barrier. Results: Pass.
- Cutting capacity: Demonstrates a smooth cut and that there is no plucking during the cutting performance. Results: Pass.
- Holding force: Demonstrates a comparable holding force as the reference model. Results: Pass.
- Preparation: Demonstrates the sufficient stability and ability to hold the maximum load to ensure adequate performance and work properly and safely in clinical use. Results: Pass.
The results of the design verification testing demonstrate that the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments meet the pre-defined acceptance criteria and intended uses.
Electrical Safety: The Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments conform to IEC 60601-1:2005 and IEC 60601-2-2.
Conductivity testing: Performed according to IEC 60601-2-2. Results show that the instrument design is able to support application of HF current.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
February 20, 2018
Aesculap, Inc. Jessica Stigliano Regulatory Affairs Associate 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K170683
Trade/Device Name: Aesculap Video Assisted Thoracic Surgery (VATS) Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 12, 2018 Received: January 16, 2018
Dear Jessica Stigliano:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
Page 2 - Jessica Stigliano
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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. Jennifer R. Stevenson -S3 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
2
Indications for Use
510(k) Number (if known) K170683
Device Name
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments
Indications for Use (Describe)
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are intended for use in open or thoracoscopic surgical procedures. They are designed for cutting, manipulating, grasping, clamping, dissecting or suction.
X Prescription Use (Part 21 CFR 801 Subpart D)
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."
3
510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|--------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Jessica Stigliano 610-
984-9063 (phone)
610-791-6882 (fax)
jessica.stigliano@Aesculapimplants.com |
| TRADE NAME: | Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments |
| COMMON NAME: | Laparoscope, General & Plastic Surgery/Minimally Invasive Surgical
Instruments |
| REGULATION NUMBER: | 876.1500 – Endoscope and accessories |
| PRODUCT CODE: | GCJ |
| REVIEW PANEL: | Gastroenterology and Urology |
PRIMARY PREDICATE
- Aesculap® Thoracoscopic Instruments K944955 ●
REFERENCE DEVICE
DEVICE DESCRIPTION
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are designed for cutting, manipulating, grasping, clamping, dissecting, or suction during open, or thoracoscopic surgical procedures. The instruments are reusable and are made from Stainless Steel with monopolar capabilities. The instruments are modular, consisting of a jaw insert and insulated outer tube with interchangeable ratcheting and non-ratcheting handles. The instruments are 250mm in length with a 7mm diameter.
The instruments can be used interchangeably with either a ratcheting or non-ratcheting handle. The handles are made from PEEK with a HF connection that fits any standard monopolar cable.
The instruments can be used with a visualization system to allow for better visibility during the procedure. This is an independent system and is not system specific. No new visualization systems are being introduced by Aesculap® in this submission.
INDICATIONS FOR USE
Aescular® Video Assisted Thoracic Surgery (VATS) Instruments are intended for use in open or thoracoscopic surgical procedures. They are designed for cutting, manipulating, grasping, clamping, dissecting or suction.
4
TECHNOLOGICA InCHARACTERISTICS (compared to Primary Predicate and reference devices)
Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are substantially equivalent to the primary predicate Aesculap® Thoracoscopic Instruments (K944955) and comparable to the reference devices, AdTec® (K160393) and Integra™Jarit® Video Assisted Thoracic Surgery (VATS) Instruments (K120012). The table below provides a comparison between the subject device and primary predicate and reference devices. The minor differences in technological characteristics do not raise questions of safety or effectiveness, as confirmed by the testing and validation activities described in the submission.
| | New device
Aesculap® Video
Assisted Thoracic
Surgery (VATS)
Instruments | Primary Predicate device
Aesculap® Thoracoscopic
Instruments (K944955) | Reference device
AdTec®(K160393) | Reference device
Integra™Jarit® Video Assisted
Thoracic Surgery (VATS)
Instruments (K120012) |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Aesculap® VATS
Instruments are
intended for use in
open, mini-open, or
thoracoscopic surgical
procedures. They are
designed for cutting,
manipulation.
grasping, clamping,
dissecting, or suction. | Aesculap® Thoracoscopic
Instruments are intended
for use in thoracoscopy.
They are used to cut,
manipulate, grasp, suture,
ligate, suction, irrigate,
and/or cauterize selected
tissue. | Aesculap®'s AdTec®
system is indicated for
use in adult and pediatric
(3.5mm instruments
only) diagnostic and
therapeutic general
endoscopy and
laparoscopy surgery. | Integra™Jarit® Video Assisted
Thoracic Surgery (VATS)
Instruments are manually
operated instruments designed to
perform specific functions such as
cutting, grasping, clamping,
dissecting, probing, draining,
aspirating, suturing, or ligating
during open, mini-open, or
thoracoscopic procedures. |
| Instruments: | | | | |
| Material | Stainless Steel | Stainless Steel | Stainless Steel | Stainless Steel |
| Features | • Modular
• Insulated
• Reusable
• Monopolar
capability | • Modular & non-
• modular
• Reusable
• Insulated
• Selected monopolar
capability | • Modular
• Insulated
• Reusable/disposable
• Monopolar/bipolar
capabilities | • Single or dual pivot
• Reusable
• Manually operated |
| Types | • Scissors
• Forceps
• Needleholders
• Clamps
• Dissectors
• Suction/Irrigation | • Scissors
• Forceps
• Needleholders
• Clamps
• Dissectors
• Suction/Irrigation | • Scissors
• Forceps
• Clamps
• Suction/Irrigation | • Scissors
• Forceps
• Clamps
• Dissectors
• Needleholders
• Suction/Irrigation |
| Dimensions | Length: 250mm
Diameter: 7mm | Length: 220mm – 450mm
Diameter: 5mm - 10mm | Length: 220 – 420mm
Diameter: 3.5, 5, and
10mm | Length: 227mm – 500mm
Diameter: 5mm - 10mm |
| Handles: | | | | |
| Style | • Ring Handle
• Ratcheted and non-
ratcheted | • Ring handle
• Ratcheted and non-
ratcheted | • Ring handle axial or
angled
• Ratcheted/non-
ratcheted | • Curved and straight
• Ratcheted and non-ratcheted |
| Material | PEEK | Stainless Steel | PEEK | Stainless Steel |
| Insulation tube: | | | | |
| Material | PEEK | Teflon | PEEK | N/A |
PERFORMANCE DATA
Design Verification
The following design verification testing was completed for the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments:
5
| Test | Test Purpose | Results |
|---|---|---|
| Blocking function | Demonstrates single actuating element allows for temporary actuation | Pass |
| of the barrier and latching and unlocking of the barrier | ||
| Cutting capacity | Demonstrates a smooth cut and that there is no plucking during the | Pass |
| cutting performance | ||
| Holding force | Demonstrates a comparable holding force as the reference model | Pass |
| Preparation | Demonstrates the sufficient stability and ability to hold the maximum | Pass |
| load to ensure adequate performance and work properly and safely in | ||
| clinical use |
The results of the design verification testing demonstrate that the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments meet the pre-defined acceptance criteria and intended uses.
Electrical Safety
The Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments conform to the following electrical safety and EMC standards;
- · IEC 60601-1:2005 Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance
- · IEC 60601-2-2 International Electrotechnical Commission, Medical Electrical Equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Conductivity testing
Conductivity testing according to IEC 60601-2-2 was performed to determine the electrical conductivity of the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments. Results of the testing show that the instrument design is able to support application of HF current.
Biocompatibility
The contact classification for the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments is surface contact less than 24 hours. Surgical grade stainless steel (ISO 7153-1) and PEEK have been successfully used in the clinical environment for many years. These materials have also been accepted in other systems marketed by Aesculap®, such as the reference device AdTec® (K160393). No new materials have been added.
The materials in the patient contacting Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments conform to the following standards;
- DIN EN ISO 7153-1: Surgical Instruments -- Metallic Materials -- Part 1: Stainless Steel
- ISO 10993-5: Biological Evaluation Of Medical Devices Part 5: Tests For In ● Vitro Cytotoxicity
- 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Cleaning/Sterilization
The Video Assisted Thoracic Surgery (VATS) Instruments are provided non-sterile and are intended to be cleaned and sterilized prior to use. Sterilization of instruments is to be
6
accomplished by steam autoclave (moist heat) in a standard pre-vacuum cycle. Cleaning and sterilization parameters are provided in the Instructions for Use for the instruments.
The cleaning and sterilizations provided in this submission conform to the following standards and guidance documents:
- . AAMI TIR12:2010 Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities. A guide for Device Manufacturers
- . AAMI TIR30:2011 A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices
- . ANSI/AAMI ST81:2004 (R2010) Sterilization of medical devices – Information to be provided by the manufacturer for processing of resterilizable medical devices.
- . FDA Guidance, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. March 17, 2015
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believe that the Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are substantially equivalent to the primary predicate, Aesculap® Thoracoscopic Instruments (K944955). As outlined in the comparison table above, the subject device shares similar indications, designs, dimensions, materials, and principals of operation with the primary predicate and reference devices, AdTec® (K160393) and Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments (K120012).
CONCLUSION
The purpose of this 510(k) premarket notification is to gain marketing clearance for the new Video Assisted Thoracic Surgery (VATS) Instruments presented in this submission. The K170683 device instruments are as and equivalent to the primary predicate indications, design / features, components, dimensional ranges, and fundamental scientific technology.