(28 days)
Not Found
No
The document describes a laser system for surgical procedures and lithotripsy. There is no mention of AI or ML in the intended use, device description, or performance studies. The software verification tests mentioned are standard for medical device software and do not indicate AI/ML.
Yes
The device is intended for the treatment of various medical conditions, including incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue in urology, lithotripsy, gastroenterological surgery, and gynecological surgery. These actions are therapeutic interventions.
No
This device is a therapeutic device intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue using a laser, not for diagnosing medical conditions.
No
The device description clearly outlines a hardware system including a laser console, fibers, foot pedal, and accessories. While it mentions software verification tests, the core of the device is a physical laser system for surgical procedures.
Based on the provided text, the SOLTIVE™ Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- SOLTIVE's Intended Use: The SOLTIVE Laser System is intended for surgical procedures performed on the body (incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue) in various anatomical sites. It directly interacts with the patient's tissues.
- Device Description: The description details a laser system that delivers energy to the treatment zone via an optical fiber. This is a therapeutic device, not a diagnostic one that analyzes samples.
The information provided clearly indicates that the SOLTIVE Laser System is a surgical tool used for treating conditions within the body, not for analyzing samples outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology:
· Ablation of Benign Prostatic Hypertrophy) [BPH]• Laser Resection of the Prostrate (LRP)• Laser Enucleation of the Prostate (LEP) · Laser Ablation of the Prostate (LAP) · Transurethral Incision of the Prostate (TUIP) · Condylomas · Urethral strictures · Lesions of external genitalia · Bladder neck incisions (BN) · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors Endoscopic fragmentation of ureteral, bladder, and renal calculi• Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy Indications:
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones • Endoscopic fragmentation of calculi • Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology:
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
· Appendectomy · Angiodysplasia · Polyps · Colorectal cancer · Biopsy · Telangiectasias
• Gall Bladder calculi • Telangiectasias of the Osler-Weber-Renu disease • Biliary/Bile duct calculi • Vascular Malformation . Ulcers . Gastric ulcers . Esophagitis . Duodenal ulcers . Esophageal ulcers . Non Bleeding Ulcers · Varices · Pancreatitis · Colitis · Haemorrhoids · Mallory-Weiss tear · Cholecystectomy · Gastric Erosions • Benign and Malignant Neoplasm
Gynecology:
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser, producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam.
The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns.
The system includes:
- Laser console ●
- Laser fibers sterile single use and reusable ●
- Foot pedal, wireless or wired ●
- Accessories power cord, HDMI cable, safety goggles/glasses, fiber cutter, .
- fiber cleaver, fiber gripper, sterilization trav, cart .
The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, prostate, urethra, ureters, bladder, kidneys, gastrointestinal tract (appendix, colon, rectum, stomach, duodenum, esophagus, pancreas, gallbladder, bile duct), female reproductive organs.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification tests were conducted in support of the subject software modification. Testing demonstrated that all performance requirements met the prescribed acceptance criteria.
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.
Not Found
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 3, 2021
Gyrus ACMI, Inc. Julie Acker Program Manager, Regulatory Affairs 800 West Park Drive Westborough, Massachusetts 01581
Re: K211401
Trade/Device Name: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: May 5, 2021 Received: May 6, 2021
Dear Julie Acker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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/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 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 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.
Purva Pandya 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
Enclosure
2
Indications for Use
510(k) Number (if known) K211401
Device Name
SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories)
Indications for Use (Describe)
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology:
· Ablation of Benign Prostatic Hypertrophy) [BPH]• Laser Resection of the Prostrate (LRP)• Laser Enucleation of the Prostate (LEP) · Laser Ablation of the Prostate (LAP) · Transurethral Incision of the Prostate (TUIP) · Condylomas · Urethral strictures · Lesions of external genitalia · Bladder neck incisions (BN) · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors Endoscopic fragmentation of ureteral, bladder, and renal calculi• Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy Indications:
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones • Endoscopic fragmentation of calculi • Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology:
Open and endoscopic gastroenterology surgery (incision, resection, ablation,
vaporization, coagulation and haemostasis) including:
· Appendectomy · Angiodysplasia · Polyps · Colorectal cancer · Biopsy · Telangiectasias
• Gall Bladder calculi • Telangiectasias of the Osler-Weber-Renu disease • Biliary/Bile duct calculi • Vascular
Malformation . Ulcers . Gastric ulcers . Esophagitis . Duodenal ulcers . Esophageal ulcers . Non Bleeding Ulcers · Varices · Pancreatitis · Colitis · Haemorrhoids · Mallory-Weiss tear · Cholecystectomy · Gastric Erosions • Benign and Malignant Neoplasm
Gynecology:
Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
SOLTIVE™ LASER SYSTEM
510(k) PREMARKET NOTIFICATION K211401
SECTION 5.0 - 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Gyrus ACMI, Inc. SOUTHBOROUGH, MA
5
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. SOLTIVE™ LASER SYSTEM (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories)
General Information
| Contract Manufacturer: | IPG Medical Corporation
377 Simarano Drive
Marlborough, MA 01752, USA |
|------------------------------------|------------------------------------------------------------------------------------------------------------|
| 510(k) Submitter: | Gyrus ACMI, Inc.
800 West Park Drive
Westborough, MA 01581 |
| Establishment Registration Number: | 3003790304 |
| Contact Person: | Julie Acker
Program Manager Regulatory Affairs
Phone: 484-294-6981
Email: julie.acker@olympus.com |
| Date Prepared: | May 5, 2021 |
Device Description
| Trade Name: | SOLTIVET™ Laser System
(SOLTIVET™ Pro SuperPulsed Laser,
SOLTIVE™ Premium SuperPulsed
Laser, SOLTIVET™ Laser Fibers, and
Accessories) |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Generic/Common Name: | Laser Instrument for Use in General
Surgery |
| Classification Name: | Laser Instrument for Use in General
Surgery |
| Regulation/CFR Citation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Classification: | Class II |
| Review Panel: | Gastroenterology/Urology |
Predicate DevicesSOLTIVE Laser Systems
6
Comparison to Predicate Device:
The subject of this 510(k) is a modification to the SOLTIVE Laser Systems to update the application software to Version 2.1. The device hardware design is identical to the predicate. The subject change to the software updates the graphical user interface and corresponding changes to the Instructions for Use. The predicate Soltive application software offers standard factory presets for procedures commonly performed using the Soltive Laser System. The modified software Version 2.1 adds a factory preset within the Lithotripsy menu for Ureteral Stone procedures, as well as other enhancements.
Product Description
The SOLTIVE Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is a thulium laser, producing a pulsed beam of coherent near-infrared light (1940 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The SOLTIVE Laser System is equipped with a 550 nm aiming beam.
The SOLTIVE Laser System is produced in two models, the SOLTIVE™ Premium SuperPulsed Laser and SOLTIVE™ Pro SuperPulsed Laser. The Premium has a maximum power output of 60 Watts and a maximum Frequency output of 2400 Hz. A secondary, foldable screen is provided. The Pro can operate at a maximum power of 35 Watts and Frequency limited to 100Hz. Both systems are operated with a wireless footswitch or wired footswitch, and both systems can utilize an auxiliary video monitor to display operating parameters. The Premium and Pro Laser must be used with a SOLTIVE Laser Fiber, offered in diameters from 150 - 940 microns.
The system includes:
- Laser console ●
- Laser fibers sterile single use and reusable ●
- Foot pedal, wireless or wired ●
- Accessories power cord, HDMI cable, safety goggles/glasses, fiber cutter, .
- fiber cleaver, fiber gripper, sterilization trav, cart .
The devices do not incorporate medicinal substances, tissues, or blood products. The laser fibers are single-use and reusable, and both single-use and reusable are initially sterilized by Ethylene Oxide. Fibers are compatible with the Olympus endoscope models as listed on the IFU.
7
Technological Characteristics
The proposed SOLTIVE Laser System with application software Version 2.1 has the identical intended use, design, and scientific technology as the predicate SOLTIVE Laser System (K183647). The subject modification is solely an update to the application software to add a Ureteral Stone preset to the menu of factory presets, and other enhancements. There are no new issues of safety or effectiveness with the proposed device.
Material
No material changes were made to the SOLTIVE Laser System cleared under K183647.
Indications for Uses
The indications for use of the modified device, as described in its labeling, have not changed as a result of the modification.
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology
- · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
- · Laser Resection of the Prostrate (LRP)
- · Laser Enucleation of the Prostate (LEP)
- · Laser Ablation of the Prostate (LAP)
- · Transurethral Incision of the Prostate (TUIP)
- Condylomas
- Urethral strictures
- · Lesions of external genitalia
- · Bladder neck incisions (BNI)
- · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
- · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
· Treatment of distal impacted fragments remaining in the ureters following lithotripsy
Lithotripsy and Percutaneous Urinary Lithotripsy Indications
• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- · Endoscopic fragmentation of calculi
8
· Treatment of distal impacted fragments of steinstrasse when guide wire cannot be Passed
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:
• Vascular Malformation
- · Appendectomy
- Polyps · Biopsy
- · Angiodysplasia • Colorectal cancer
- Telangiectasias
• Gastritis
• Colitis
• Esophagitis
- Telangiectasias of the Osler-Weber-Renu disease
- Biliary/Bile duct calculi
• Gall Bladder calculi
• Non Bleeding Ulcers
- · Ulcers
- Gastric ulcers
- Duodenal ulcers
- · Varices
- · Pancreatitis
- Mallory-Weiss tear
• Esophageal ulcers
- Haemorrhoids • Cholecystectomy
- · Gastric Erosions
- · Benign and Malignant Neoplasm
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
Compliance to Voluntary Standards
The design of the SOLTIVE Laser System complies with the following standards:
| Standard | Title |
|---|---|
| EN ISO 14971:2019 | Medical devices -- Application of risk management to medical |
| devices | |
| ISO 15223-1:2016 | Medical devices -- Symbols to be used with medical device |
| labels, labeling and information to be supplied -- Part 1: | |
| General requirements | |
| IEC 60601- | |
| 1:2005+A1:2012 | Medical electrical equipment - Part 1: General requirements |
| for basic safety and essential performance | |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General |
| requirements for basic safety and essential performance - | |
| Collateral standard: Electromagnetic compatibility - | |
| Requirements and tests | |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification |
| and requirements | |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability |
| engineering to medical devices | |
| IEC 60601-2- | Medical electrical equipment - Part 2-22: Particular |
| Standard | Title |
| 22:2007+A1:2012 | requirements for basic safety and essential performance of |
| surgical, cosmetic, therapeutic and diagnostic laser | |
| equipment | |
| IEC 60601-1- | |
| 6:2010+A1:2013 | Medical electrical equipment - Part 1-6: General |
| requirements for basic safety and essential performance - | |
| Collateral standard: Usability | |
| IEC | |
| 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices -- Part 1: |
| Requirements for materials, sterile barrier systems and | |
| packaging systems | |
| ISO 11135:2014 | Sterilization of health care products -- Ethylene oxide: |
| Requirements for development, validation and routine | |
| control of a sterilization process for medical devices | |
| ISO 10993-1:2018 | Biological evaluation of medical devices -- Part 1: |
| Evaluation and testing | |
| ISO 10993-5:2009 | Biological evaluation of medical devices -- Part 5: Tests for |
| in vitro cytotoxicity | |
| ISO 10993- | |
| 7:2008+COR1:2009 | Biological evaluation of medical devices -- Part 7: Ethylene |
| oxide sterilization residuals | |
| ISO 10993-10:2010 | Biological evaluation of medical devices -- Part 10: Tests |
| for irritation and delayed-type hypersensitivity | |
| ISO 10993-11:2017 | Biological evaluation of medical devices -- Part 11: Tests |
| for systemic toxicity | |
| ASTM F 1980-16 | Standard Guide for Accelerated Aging of Sterile Barrier |
| Systems for Medical Devices | |
| ASTM | |
| F1886/F1886M:2016 | Standard Test Method for Determining Integrity of Seals for |
| Flexible Packaging by Visual Inspection | |
| ASTM F88- | |
| 15/F88M-15 | Standard Test Method for Seal Strength of Flexible Barrier |
| Materials | |
| ISO 17665- | |
| 1:2006/R2013 | Sterilization of health care products -- Moist heat -- Part 1: |
| Requirements for the development, validation and routine | |
| control of a sterilization process for medical devices | |
| ISO | |
| 14937:2009/R2013 | Sterilization of health care products -- General requirements |
| for characterization of a sterilizing agent and the | |
| development, validation and routine control of a sterilization | |
| process for medical devices | |
| ISTA Procedure 3A | |
| 2018 | Packaged Products for Parcel Delivery System Shipment 70kg |
| (150 lb) or less | |
| ASTM D4169-16 | Performance Testing of Shipping Containers and Systems |
| ASTM F2096-11 | Standard Test Method for Detecting Gross Leaks in Porous |
| Medical Packaging by Internal Pressurization (Bubble Leak) |
9
10
Summary of Sterilization and Shelf-Life Discussion
SOLTIVE SuperPulsed Laser Fibers Single-use and SOLTIVE SuperPulsed Laser Fibers Reusable are provided sterile. The devices are sterilized by Ethylene Oxide to a provide sterility assurance level of 10-6.
The Shelf-Life period for the Single-use fibers was determined via testing and through an analysis of the shelf-life stability of the materials used in the design of the device, as well as an analysis of the packaging materials and processes used with other Gyrus ACMI devices. Shelf-life studies are on file to support the labeled shelf life.
Summary of All Performance Testing (bench, clinical, non-clinical)
Software verification tests were conducted in support of the subject software modification. Testing demonstrated that all performance requirements met the prescribed acceptance criteria.
Substantial Equivalence
Substantial equivalence is demonstrated by acknowledged verification/validation activities. The subject devices have identical technology, performance, dimensions, and materials. The differences to the predicate device SOLTIVE Laser Systems are:
- Revised software to update the graphical user interface to add a Ureteral Stone . preset to the menu of Lithotripsy presets and other enhancements.
- . Updated Instructions for Use to align with updated graphical user interface.
11
| Gyrus ACMI SOLTIVE Laser System | |||
|---|---|---|---|
| Design | |||
| Feature | Proposed | ||
| (Software Version 2.1) | Predicate K183647 | ||
| (Software Version 2.0) | Comparison | ||
| Intended Use | The SOLTIVE Laser | ||
| System is intended for use | |||
| in surgical procedures such | |||
| as open laparoscopic and | |||
| endoscopic, involving | |||
| endoscopic ablation, | |||
| vaporization, excision, | |||
| incision, resection, | |||
| coagulation and hemostasis | |||
| of soft tissue in medical | |||
| specialties including: | |||
| Urology, lithotripsy, | |||
| gastroenterology, | |||
| arthroscopy, discectomy, | |||
| gynecology, ENT and | |||
| general surgery. | The SOLTIVE Laser | ||
| System is intended for use | |||
| in surgical procedures such | |||
| as open laparoscopic and | |||
| endoscopic, involving | |||
| endoscopic ablation, | |||
| vaporization, excision, | |||
| incision, resection, | |||
| coagulation and hemostasis | |||
| of soft tissue in medical | |||
| specialties including: | |||
| Urology, lithotripsy, | |||
| gastroenterology, | |||
| arthroscopy, discectomy, | |||
| gynecology, ENT and | |||
| general surgery. | Identical | ||
| Function of | |||
| Device | Thulium Laser | ||
| generator with fiber | |||
| optic delivery | Thulium Laser | ||
| generator with fiber | |||
| optic delivery | Identical | ||
| Mechanics of | |||
| Action | Light/energy absorption | ||
| by target tissues | Light/energy absorption | ||
| by target tissues | Identical | ||
| Laser Source | Thulium | Thulium | Identical |
| Accessories | Surgical fibers (reusable | ||
| and single use) available in | |||
| following nominal core | |||
| diameters (150, 200, 365, | |||
| 550, 940 μm) | Surgical fibers (reusable and | ||
| single use) available in | |||
| following nominal core | |||
| diameters (150, 200, 365, | |||
| 550, 940 μm) | Identical | ||
| Biocompatible | Yes | Yes | Identical |
| Sterilization | |||
| (Single-use | |||
| fibers) | Ethylene Oxide 10-6 | Ethylene Oxide 10-6 | Identical |
| Single Use & | |||
| Reusable | |||
| Fibers | Yes | Yes | Identical |
Equivalence Comparison Table:
Conclusion:
In summary, the Gyrus ACMI SOLTIVE Laser System is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.