(267 days)
Not Found
No
The document describes a laser system with user-controlled parameters and does not mention any AI or ML components or functionalities.
Yes
The device is intended for medical applications such as incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue in various surgical fields (urology, gastroenterological surgery, gynecological surgery). These are therapeutic actions aimed at treating medical conditions.
No
The device description clearly states its intended use is for "incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue," which are all therapeutic or surgical procedures, not diagnostic ones.
No
The device description clearly outlines hardware components such as a laser console, fibers, foot pedal, and accessories, indicating it is a physical medical device system, not software-only.
Based on the provided information, the SOLTIVE™ Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue" in various surgical procedures. This describes a device used on the patient's body for treatment, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description details a laser system that delivers a beam of light to the treatment zone via a fiber. This is consistent with a surgical laser, not an IVD device which would typically involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
In summary, the SOLTIVE™ Laser System is a surgical device used for therapeutic purposes, not an IVD device used for diagnosis.
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/ureteral strictures · Lesions of external genitalia · Bladder neck incisions (BNI) · Ablation and resection of bladder tumors, and ureteral tumors, Endoscopic fragmentation of urethral, ureteral, bladder, and renal calcul · 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 renal calculi• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- Polyps
- Biopsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- · Gastric ulcers
- Duodenal ulcers
- · Non Bleeding Ulcers
- · Pancreatitis
- · Haemorrhoids
- · Cholecystectomy
- Benign and Malignant Neoplasm
- · Angiodysplasia
- Colorectal cancer
- · Telangiectasias
- · Telangiectasias of the Osler-Weber-Renu disease
- Vascular Malformation
- · Gastritis
- · Esophagitis
- · Esophageal ulcers
- · Varices
- Colitis
- · Mallory-Weiss tear
- · Gastric Erosions
Gynecology
Open, endoscopic (including hysteroscopic gynecological surgery (incision, excision, resection, 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 stripper and 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, ureter, bladder, renal, external genitalia, rectum, colon, gallbladder, biliary tract, stomach, duodenum, pancreas, anus, esophageal, vascular.
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)
Performance testing was conducted in support of the predicate devices and equivalently applies to the subject device as the labeling clarifications fall within the existing performance envelope of the laser system. Testing demonstrated that all performance requirements met the prescribed acceptance criteria, including the proposed labeling change.
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 acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.
January 27, 2023
Gyrus ACMI, Inc. Jon Gilbert Regulatory Affairs Consultant to Gyrus ACMI, Inc. 800 West Park Drive Westborough, MA 01581
Re: K221306 Trade/Device Name: SOLTIVE Laser System Regulation Number: 21 CFR§ 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: December 16, 2022 Received: December 19, 2022
Dear Jon Gilbert:
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.
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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology 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) K221306
Device Name SOLTIVE Laser System
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
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/ureteral strictures · Lesions of external genitalia · Bladder neck incisions (BNI) · Ablation and resection of bladder tumors, and ureteral tumors, Endoscopic fragmentation of urethral, ureteral, bladder, and renal calcul · 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 renal calculi• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
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.
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
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) including:
- · Appendectomy
- Polyps
- Biopsy
- Gall Bladder calculi
- Biliary/Bile duct calculi
- Ulcers
- · Gastric ulcers
- Duodenal ulcers
- · Non Bleeding Ulcers
- · Pancreatitis
- · Haemorrhoids
- · Cholecystectomy
- Benign and Malignant Neoplasm
- Gynecology
Open, endoscopic (including hysteroscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
Type of Use (Select one or both, as applicable)
Use (Part 21 CFR 801 Subpart D)
The-Counter Use (21 CFR 801 Subpart C)
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 STAF
The burden time for this collection of information is estimated to avera time to review instructions, search existing data sources, gather and n and review the collection of information. Send comments regarding of this information collection, including suggestions for reducin
enartment of Health ar tion Act (
"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 valio
-
EF 00 11: 443-6740
46 -
· Angiodysplasia
-
Colorectal cancer
-
· Telangiectasias
-
· Telangiectasias of the Osler-Weber-Renu disease
-
Vascular Malformation
-
· Gastritis
-
· Esophagitis
-
· Esophageal ulcers
-
· Varices
-
Colitis
-
· Mallory-Weiss tear
-
· Gastric Erosions
4
K221306 Page 1 of 7
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: | Jon Gilbert fbo Julie Acker
Regulatory Affairs Consultant
Phone: 906.361.3237
Email: jgilb.raca@gmail.com |
| Date Prepared: | May 3, 2022 |
Device Description
| Trade Name: | SOLTIVE Laser System |
|---|---|
| Generic/Common Name: | Laser Instrument for Use in |
| General Surgery | |
| Classification Name: | Laser Surgical Instrument for Use |
| in General and Plastic Surgery and | |
| in Dermatology | |
| Regulation/CFR Citation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Classification: | Class II |
| Review Panel: | Gastroenterology/Urology |
Predicate Devices
| SOLTIVE Laser Systems | K211401, K183647 |
|---|---|
| ----------------------- | ------------------ |
5
K221306 Page 2 of 7
Comparison to Predicate Device:
The subject of this 510(k) is a labeling modification to the SOLTIVE Laser Systems. The device hardware and software design is identical to the predicate. The subject change to the labeling clarifies currently cleared Instructions for Use.
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 stripper and 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.
6
Technological Characteristics
The proposed SOLTIVE Laser System with modified labeling has the same intended use, design, and scientific technology as the predicate SOLTIVE Laser System (K183647). The subject modification is solely an update to clarify the use of the laser system in urological and gynecological tissues.
Material
No material changes were made to the SOLTIVE Laser System cleared under the predicate devices.
Indications for Uses
The indications for use of the modified device, as described in its labeling, have not changed the intended clinical applications as a result of the modification.
The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVETM 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 / ureteral 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
7
51
· Treatment of distal impacted fragments of steinstrasse when guide wire cannot be Passed
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:
-
· Appendectomy
• Gall Bladder calculi -
Polyps · Biopsy
-
· Angiodysplasia • Colorectal cancer
-
Telangiectasias of the Osler-Weber-Renu disease
-
Biliary/Bile duct calculi
-
Ulcers
-
Gastric ulcers
-
Duodenal ulcers
-
Non Bleeding Ulcers
-
Pancreatitis
-
Mallory-Weiss tear
-
Cholecystectomy
-
Benign and Malignant Neoplasm
Gynecology
Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
Compliance to Voluntary 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) |
• Telangiectasias
- Vascular Malformation
- Gastritis
- Esophagitis
- Esophageal ulcers
- Varices • Colitis
- Haemorrhoids
- · Gastric Erosions
8
9
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)
Performance testing was conducted in support of the predicate devices and equivalently applies to the subject device as the labeling clarifications fall within the existing performance envelope of the laser system. Testing demonstrated that all performance requirements met the prescribed acceptance criteria, including the proposed labeling change.
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:
- Clarified labeling for urological and gynecological surgery. ●
- . Updated Instructions for Use to align with updated labeling.
10
K221306 Page 7 of 7
Equivalence Comparison Table:
| Gyrus ACMI SOLTIVE Laser System | |||
|---|---|---|---|
| Design | |||
| Feature | Proposed | Predicate K211401 | 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. | Equivalent | ||
| 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 |
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.