(253 days)
No
The summary describes electrosurgical knives and accessories for cutting and lifting tissue using high-frequency current and saline, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes.
The device is used to cut tissue and lift mucosal lesions in the digestive tract, which are therapeutic actions.
No
The device description and intended use state that the instruments are designed to "cut tissue using high-frequency current" and "induce sterile normal saline to lift mucosal lesions." These are therapeutic or interventional actions, not diagnostic ones. Performance studies are related to these actions (e.g., cutting and lifting efficacy, safety), not to identifying or characterizing a disease or condition.
No
The device description explicitly states that the system consists of "electrosurgical knives (subject devices), flushing pump, and water tubes (accessories)," indicating physical hardware components. The performance studies also include testing related to sterilization, biocompatibility, electrical safety, and bench performance tests involving cutting and lifting tissue, which are all indicative of a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an electrosurgical knife used within the digestive tract to cut tissue and inject saline. This is an in vivo procedure (performed within a living organism), not an in vitro test (performed outside the body).
- Intended Use: The intended use is for cutting tissue and lifting mucosal lesions using direct visualization through an endoscope, which is a surgical/interventional procedure.
- Performance Studies: The performance studies listed (sterilization, biocompatibility, electrical safety, cutting/lifting performance, thermal damage, perforation safety) are all related to the physical and functional performance of a surgical instrument, not the analytical or clinical performance of a diagnostic test.
Therefore, the device described is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KD-625
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract.
These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
KD-645
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using highfrequency current within the digestive tract.
This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
This system consists of the electrosurgical knives (subject devices), flushing pump, and water tubes (accessories). The subject devices are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. They will be marketed as sterilized (ETO) devices for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digestive tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/hospital
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)
The following performance data are being provided in support of the substantial equivalence determination.
- Sterilization/Shelf-life testing
Sterilization/shelf-life testing for the Single Use Electrosurgical Knife KD-625 and KD-645 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
Accelerated aging test for the subject devices were conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three years will be performed to demonstrate longer stability and support the results of the accelerated aging test.
- Biocompatibility testing
Biocompatibility testing for the subject devices were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay -
- Intracutaneous Study in Rabbits
- Guinea Pig Maximization Sensitization Test
- Systemic Toxicity Study in Mice
- USP Rabbit Pyrogen Study, Material Mediated
- Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject devices. The system complies with the AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2 Edition 3: 2007 standards for EMC.
- Performance testing - Bench
Bench testing for the subject devices as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed according to the design requirements and included process verification, design verification, and design validation.
- Evaluation Test for Performance to Cut Digestive Tract Mucosa
- Evaluation Test for Lifting of Digestive Tract Mucosa
- Histopathological Evaluation Test of Thermal Damage on Digestive Tract
- Evaluation Test for safety against perforation by saline feeding function
- Risk analysis
Risk analysis for the subject devices were conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
May 15, 2019
Olympus Medical Systems Corp. Daphney Germain-Kolawole Senior Proiect Manager, Regulatory Affairs Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610
Re: K182408
Trade/Device Name: Single Use Electrosurgical Knife KD-625, Single Use Electrosurgical Knife KD-645 Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KNS Dated: March 25, 2019 Received: March 26, 2019
Dear Daphney Germain-Kolawole:
This letter corrects our substantially equivalent letter of May 15, 2019.
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
1
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) 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 (QS) 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 mediation-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 Shani Haugen Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182408
Device Name
Single Use Electrosurgical Knife KD-625, Single Use Electrosurgical Knife KD-645
Indications for Use (Describe)
KD-625
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract.
These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
KD-645
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using highfrequency current within the digestive tract.
This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly beneath the word. The word and line are centered in the image.
Traditional 510(k) Notification Single Use Electrosurgical Knife KD-625LR/QR/UR, KD-645L, K182408
Date Prepared: March 25, 2019
510(k) Summary
5.1 GENERAL INFORMATION
| ■ 510(k) Submitter: | OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan
192-8507 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Contact Person: | Daphney Germain-Kolawole
Olympus Corporation of the Americas
3500 Corporate Parkway PO Box 610
Center Valley, PA 18034-0610, USA
Phone: 484-896-5691
Fax: 484-896-7128
Email: daphney.germain-kolawole@olympus.com |
| ■ Manufacturing site: | 2-248-1 Okkonoki, Kuroishi-shi, Aomori 036-0357,
Japan |
5.2 DEVICE IDENTIFICATION
| ■ Device Name | Single Use Electrosurgical knife KD-625
Single Use Electrosurgical knife KD-645 |
|---------------------|------------------------------------------------------------------------------------|
| ■ Common Name | Single Use Electrosurgical knife |
| ■ Regulation Number | 876.4300 |
| ■ Regulation Name | Endoscopic electrosurgical unit and accessories |
| ■ Regulatory Class | II |
| ■ Product Code | KNS |
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KD-625LR/QR/UR, KD-645L, K182408
5.3 PREDICATE DEVICE
1) Predicate device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| Single Use Electrosurgical knife | ||
| KD-655 | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K171158 |
2) Reference device
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| KD-620LR (Single Use | ||
| Electrosurgical Knife Series) | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K092309 |
Table 12-2 Reference device on KD-625
| Device name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| KD-640L (Single Use Electrosurgical | ||
| Knife Series) | OLYMPUS MEDICAL | |
| SYSTEMS CORP. | K092309 |
5.4 DEVICE DESCRIPTION
1) General Description of the subject device
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
This system consists of the electrosurgical knives (subject devices), flushing pump, and water tubes (accessories). The subject devices are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope. They will be marketed as sterilized (ETO) devices for single use.
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2) Principle of Operation
The subject devices are used in combination with an endoscope and electrosurgical generator to resect a lesion in the gastrointestinal tract using high frequency current. The KD-625 and KD-645 are composed of a handle and insertion portion. The insertion portion is inserted into the gastrointestinal organ via an endoscope.
The subject devices are connected to an electrosurgical unit through the electrode on the handle and the A cord. The electrode is electrically connected with the cutting knife through a wire, which allows cutting using electricity supplied from the electrosurgical unit. Pushing the slider of the handle allows the insertion portion to follow the slider movement and allows the cutting knife at the distal end to extend. Holding the extended cutting knife against the target tissue enables dissection of the tissue.
In addition, the subject devices can supply fluid into the submucosa in combination with a flushing device. Saline solution is supplied, via the channel inside the sheath, from the nozzle at the distal end through a water tube or flushing device connected to the accessory port on the handle.
5.5 INDICATIONS FOR USE
5.5.1 INDICATIONS FOR USE for KD-625
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
5.5.2 INDICATIONS FOR USE for KD-645
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract. This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
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5.6 COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEIVCE
The Single Use Electrosurgical Knife KD-625 and KD-645 have the same technological characteristics and design as the predicate device except for the following new features:
- Material and shape of the cutting knife
- Shape of the water outlet
Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety or effectiveness of the subject device.
A side-by-side comparison of the subject devices and the predicate device is provided below.
| Item |
KD-625 |
KD-645 |
KD-655 (#171158) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | These instruments
have been designed
to be used with
Olympus
endoscopes and
electrosurgical units
to cut tissue using
high-frequency
current within the
digestive tract.
These instruments
are indicated for the
induction of sterile
normal saline into
the submucosa to lift
mucosal lesions
using direct
visualization
through an
endoscope. | This instrument
has been designed
to be used with
Olympus
endoscopes and
electrosurgical units
to cut tissue using
high-frequency
current within the
digestive tract.
This instrument is
indicated for the
induction of sterile
normal saline into
the submucosa to
lift mucosal lesions
using direct
visualization
through an
endoscope. | These instruments
have been designed
to be used with
Olympus
endoscopes and
electrosurgical units
to cut tissue within
the digestive tract
and using
high-frequency
current. These
instruments are
indicated for the
induction of sterile
normal saline into
the submucosa to
lift mucosal lesions
using direct
visualization
through an
endoscope. |
| Common name | Single Use
Electrosurgical
knife | Single Use
Electrosurgical
knife | Single Use
Electrosurgical
knife |
| Regulation
number | 876.4300 | 876.4300 | 876.4300 |
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| Item |
KD-625 |
KD-645 |
KD-655 (#171158) |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation name | Endoscopic
electrosurgical unit
and accessories | Endoscopic
electrosurgical unit
and accessories | Endoscopic
electrosurgical unit
and accessories |
| Regulatory class | II | II | II |
| Classification
panel | Gastroenterology
and urology | Gastroenterology
and urology | Gastroenterology
and urology |
| Product code | KNS | KNS | KNS |
| Environment of
use | Healthcare
facility/hospital | Healthcare
facility/hospital | Healthcare
facility/hospital |
| Single/repeat use | Single-use | Single-use | Single-use |
| Sterile/non-sterile | Marketed as a
sterilized device | Marketed as a
sterilized device | Marketed as a
sterilized device |
| Sterilization
method | ETO sterile | ETO sterile | ETO sterile |
| Energy source | High-frequency
current | High-frequency
current | High-frequency
current |
| Material
composition of
main
patient-contact
parts | Stainless steel
Ceramics
ABS
PTFE
Silicone Rubber | Stainless steel
Ceramics
ABS
PTFE
Silicone Rubber | Stainless steel
Ceramics
ABS
PTFE
Silicone Rubber |
| Duration and type
of contact | Surface-contacting
device in contact
with mucosal
membranes. The
contact duration is
limited exposure
(i.e. contact is up to
24 hours). | Surface-contacting
device in contact
with mucosal
membranes. The
contact duration is
limited exposure
(i.e. contact is up to
24 hours). | Surface-contacting
device in contact
with mucosal
membranes. The
contact duration is
limited exposure
(i.e. contact is up to
24 hours). |
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Image /page/8/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly underneath the word. The font is sans-serif and the letters are closely spaced together.
5.7 PERFORMANCE DATA
The following performance data are being provided in support of the substantial equivalence determination.
1) Sterilization/Shelf-life testing
Sterilization/shelf-life testing for the Single Use Electrosurgical Knife KD-625 and KD-645 were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
Accelerated aging test for the subject devices were conducted in accordance with ASTM F1980-16, the standard guide for accelerated aging of sterile barrier systems for medical devices. The real-time aging test for three years will be performed to demonstrate longer stability and support the results of the accelerated aging test.
2) Biocompatibility testing
Biocompatibility testing for the subject devices were conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study Using the Colony Assay -
- Intracutaneous Study in Rabbits ।
- Guinea Pig Maximization Sensitization Test i
- Systemic Toxicity Study in Mice i
- USP Rabbit Pyrogen Study, Material Mediated
3) Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject devices. The system complies with the AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 and IEC 60601-2-18:2009 standards for safety and the IEC 60601-1-2 Edition 3: 2007 standards for EMC.
4) Performance testing - Bench
Bench testing for the subject devices as listed below was conducted to ensure that the subject device performs as intended and meet design specifications. Device performance was assessed according to the design requirements and included process verification, design verification, and design validation.
- Evaluation Test for Performance to Cut Digestive Tract Mucosa ।
- Evaluation Test for Lifting of Digestive Tract Mucosa ।
- Histopathological Evaluation Test of Thermal Damage on Digestive Tract i
- Evaluation Test for safety against perforation by saline feeding function i
9
Image /page/9/Picture/1 description: The image shows the word "OLYMPUS" in large, bold, blue letters. A thin, horizontal, yellow line is located directly below the word. The background is white. The logo is simple and clean.
Traditional 510(k) Notification Single Use Electrosurgical Knife KD-625LR/QR/UR, KD-645L, K182408
5) Risk analysis
Risk analysis for the subject devices were conducted in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
5.8 CONCLUSIONS
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate devices, the subject devices raise no new issue of safety and effectiveness and are substantially equivalent to the predicate devices in terms of safety, efficacy and performance.