(85 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical and optical components.
Yes
Explanation: The device is used for "minimally invasive ligament or fascia release" in conditions like carpal tunnel, cubital tunnel, and trigger finger, which are direct treatments for medical conditions.
No
Explanation: The device is intended for surgical release procedures (e.g., carpal tunnel release, cubital tunnel release, trigger finger release) and is described as a surgical system with blades and instruments, not for diagnosing conditions.
No
The device description explicitly lists hardware components: SmartRelease Endoscope, SmartRelease Handpiece, SmartRelease Standard and Onyx Blade Assemblies, and accessory Manual Surgical Instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "minimally invasive ligament or fascia release" and specifically lists surgical procedures like carpal tunnel release, cubital tunnel release, and trigger finger release. These are surgical interventions performed directly on the patient's body.
- Device Description: The device components are surgical instruments (endoscope, handpiece, blade assemblies, manual surgical instruments) used for cutting and manipulating tissue during surgery.
- Anatomical Site: The anatomical sites are parts of the body (wrist, elbow, hand) where surgical procedures are performed.
- Intended User: The intended user is a "Surgeon in a health care facility," which is consistent with a surgical device.
- Performance Studies: The performance studies involve user validation in cadaver labs, evaluating the surgical procedure itself.
In Vitro Diagnostic (IVD) devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens. It is a surgical tool used on the body.
N/A
Intended Use / Indications for Use
The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is intended for use in minimally invasive ligament or fascia release.
Indications for Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is indicated for:
- Carpal tunnel release in the wrist
- Cubital tunnel release in the elbow
- Trigger finger release in the hand
Product codes
HRX, KCT, EMF
Device Description
MicroAire's SmartRelease Endoscopic Soft Tissue Release System is comprised of the following components: the SmartRelease Endoscope, the SmartRelease Handpiece, and the SmartRelease Standard and Onyx Blade Assemblies. The system includes a set of accessory Manual Surgical Instruments. The SmartRelease Handpiece, the SmartRelease Endoscope, and the Manual Surgical Instruments are reusable after cleaning and subsequent sterilization. The SmartRelease Blade Assemblies are gamma sterilized and intended for single-use only.
Carpal Tunnel:
The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The carpal tunnel device attaches to any standard video camera and light source used in endoscopic/arthroscopy procedures. The surgeon introduces the Disposable Blade assembly into the carpal tunnel through an incision in the proximal wrist flexion crease. Viewing the deep side of the transverse carpal ligament (flexor retinaculum) through a window at the tip of the instrument, the surgeon elevates the blade to cut the ligament as the instrument is withdrawn.
Cubital Tunnel:
The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The cubital tunnel device attaches to any standard video camera and light source used in endoscopic procedures. The surgeon introduces the disposable blade assembly into the cubital tunnel through a 3-cm longitudinal incision between the medial epicondyle and olecranon. Viewing the roof of the cubital tunnel fascia through a window at the tip of the instrument, the surgeon elevates the blade to cut the instrument is withdrawn.
Trigger Finger:
The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The trigger finger device attaches to any standard video camera and light source used in endoscopic procedures. The surgeon introduces the disposable blade assembly into the finger through a 1-cm incision crease of the affected finger. Viewing the roof of the A1 Pulley through a window at the tip of the instruments, the surgeon elevates the blade to cut the pulley as the instrument is withdrawn.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, elbow, hand (fingers and thumbs)
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)
User Validation: Twenty users participated in cadaver labs with the subject device, walking through the procedure for trigger finger release on both fingers and thumbs on multiple hands each, for a total evaluation of 80 fingers and 40 thumbs. The results confirm that the SmartRelease Endoscopic Soft Tissue Release System 1) presents no usability risks, 2) can be safely and effectively used as intended, and 3) meets the User Needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
0
February, 2, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
MicroAire Surgical Instruments Glenn Gerstenfeld Vice President, QA/RA & Compliance Officer 3590 Grand Forks Blvd Charlottesville, Virginia 22911
Re: K223406
Trade/Device Name: SmartRelease® Endoscopic Soft Tissue Release System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, KCT, EMF Dated: November 4, 2022 Received: November 9, 2022
Dear Glenn Gerstenfeld:
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. 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
1
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 medical devices and radiation-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,
Sara S. Thompson -S
For
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223406
Device Name
SmartRelease® Endoscopic Soft Tissue Release System
Indications for Use (Describe)
The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is indicated for:
- · Carpal tunnel release in the wrist
- Cubital tunnel release in the elbow
- · Trigger finger release in the hand
| 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
Section 5: 510(k) Summary
SmartRelease® Endoscopic Soft Tissue Release System
1. Submission Sponsor
MicroAire® Surgical Instruments, LLC
3590 Grand Forks Blvd.
Charlottesville, VA 22911
USA
Contact: Glenn Gerstenfeld
Title: VP, QA/RA and Compliance Officer
Phone: (434) 975-8344
Fax: (434) 975-4144
2. Date Prepared
November 4, 2022
3. Device Identification
Trade/Proprietary Name: SmartRelease Endoscopic Soft Tissue Release System Common/Usual Name: SmartRelease Classification Name: Arthroscope Regulation Number: 21 CFR 888.1100 Product Code: HRX, KCT, EMF Class: Class II Classification Panel: Orthopedic
4. Predicate Device(s)
The predicate device for this submission is MicroAire's SmartRelease® Endoscopic Soft Tissue Release System (K181819). This predicate has not been the subject of a design-related recall. No reference devices were used in this submission.
4
5. Intended Use / Indication for Use Statement
Intended Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is intended for use in minimally invasive ligament or fascia release.
Indications for Use: The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is indicated for:
- Carpal tunnel release in the wrist
- . Cubital tunnel release in the elbow
- Trigger finger release in the hand
6. Device Description
MicroAire's SmartRelease Endoscopic Soft Tissue Release System is comprised of the following components: the SmartRelease Endoscope, the SmartRelease Handpiece, and the SmartRelease Standard and Onyx Blade Assemblies. The system includes a set of accessory Manual Surgical Instruments. The SmartRelease Handpiece, the SmartRelease Endoscope, and the Manual Surgical Instruments are reusable after cleaning and subsequent sterilization. The SmartRelease Blade Assemblies are gamma sterilized and intended for single-use only.
Carpal Tunnel:
The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The carpal tunnel device attaches to any standard video camera and light source used in endoscopic/arthroscopy procedures. The surgeon introduces the Disposable Blade assembly into the carpal tunnel through an incision in the proximal wrist flexion crease. Viewing the deep side of the transverse carpal ligament (flexor retinaculum) through a window at the tip of the instrument, the surgeon elevates the blade to cut the ligament as the instrument is withdrawn.
Cubital Tunnel:
The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The cubital tunnel device attaches to any standard video camera and light source used in endoscopic procedures. The surgeon introduces the disposable blade assembly into the cubital tunnel through a 3-cm longitudinal incision between the medial epicondyle and olecranon. Viewing the roof of the cubital tunnel fascia through a window at the tip of the instrument, the surgeon elevates the blade to cut the instrument is withdrawn.
Trigger Finger:
The MicroAire SmartRelease Endoscopic Soft Tissue Release System is comprised of an endoscope and a handpiece that holds a Disposable Blade assembly. The trigger finger device attaches to any standard video camera and light source used in endoscopic procedures. The surgeon introduces the
5
disposable blade assembly into the finger through a 1-cm incision crease of the affected finger. Viewing the roof of the A1 Pulley through a window at the tip of the instruments, the surgeon elevates the blade to cut the pulley as the instrument is withdrawn.
7. Substantial Equivalence Discussion
Technological Characteristics
This submission is to add an Indication for Use to the SmartRelease Endoscopic Soft Tissue Release System and does not include any design changes to the product family. There have been no design changes between the originally cleared SmartRelease Endoscopic Soft Tissue Release System and the proposed product family. Thus, the two SmartRelease devices have technological characteristics as there have been no changes to the design, material, chemical composition, energy source, manufacturing, packaging, or sterilization of the device, as summarized in the table below.
| Technological
Characteristic | SUBJECT
SmartRelease Endoscopic Soft
Tissue Release System | PREDICATE
510(K) K181819
SmartRelease Endoscopic Soft
Tissue Release System | Comparison |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Design | | | |
| Mechanism of
Action | The blade assembly locks onto the front of the handpiece. The endoscope is inserted through the handpiece into the blade assembly. A light source and camera are attached to the endoscope. When the blade assembly is inserted into the surgical site, the endoscope provides a view of the distal end of the blade assembly and tissue to be resected. When the user pulls the trigger on the handpiece, it advances the shuttle into the proximal end of the blade assembly, pushing the actuator forward. This forward movement of the actuator raises the cutting blade along a track in the blade case. With the cutting blade fully raised, the user can slowly pull the assembly back out of the surgical site, allowing the cutting blade to | The blade assembly locks onto the front of the handpiece. The endoscope is inserted through the handpiece into the blade assembly. A light source and camera are attached to the endoscope. When the blade assembly is inserted into the surgical site, the endoscope provides a view of the distal end of the blade assembly and tissue to be resected. When the user pulls the trigger on the handpiece, it advances the shuttle into the proximal end of the blade assembly, pushing the actuator forward. This forward movement of the actuator raises the cutting blade along a track in the blade case. With the cutting blade fully raised, the user can slowly pull the assembly back out of the surgical site, allowing the cutting blade to | Identical to
predicate device |
| Technological
Characteristic | SUBJECT
SmartRelease Endoscopic Soft
Tissue Release System | PREDICATE
510(K) K181819
SmartRelease Endoscopic Soft
Tissue Release System | Comparison |
| | resect the tissue of interest.
When the trigger is released, the
force of the shuttle on the
actuator is removed, and a spring
in the blade assembly returns the
actuator and cutting blade to their
original, retracted position. | resect the tissue of interest.
When the trigger is released, the
force of the shuttle on the
actuator is removed, and a spring
in the blade assembly returns the
actuator and cutting blade to their
original, retracted position. | |
| Materials | • Handpiece – aluminum,
stainless steel, Radel | • Handpiece – aluminum,
stainless steel, Radel | Identical to
predicate device |
| | • Blade Assemblies –
polyetherimide,
polyacrylamide, stainless steel | • Blade Assemblies –
polyetherimide,
polyacrylamide, stainless steel | |
| | • Endoscope – stainless steel,
titanium, PEEK, Sapphire glass,
CASTIN lead-free solder | • Endoscope - stainless steel,
titanium, PEEK, Sapphire glass,
CASTIN lead-free solder | |
| | • Sterilization Tray – stainless
steel, silicone | • Sterilization Tray – stainless
steel, silicone | |
| | • Accessory Instruments -
stainless steel | • Accessory Instruments -
stainless steel | |
| Single-Use /
Reusable | • Blade Assemblies are single
use, disposable devices | • Blade Assemblies are single
use, disposable devices | Identical to
predicate device |
| | • Handpiece, endoscope,
sterilization tray, and accessory
instruments are reusable
devices | • Handpiece, endoscope,
sterilization tray, and accessory
instruments are reusable
devices | |
| Shelf Life | Blade Assemblies have 4 year shelf
life | Blade Assemblies have 4 year shelf
life | Identical to
predicate device |
| Energy Output | None | None | Identical to
predicate device |
| Battery Operated | No | No | Identical to
predicate device |
| AC Powered | No | No | Identical to
predicate device |
| Technological
Characteristic | SUBJECT
SmartRelease Endoscopic Soft
Tissue Release System | PREDICATE
510(K) K181819
SmartRelease Endoscopic Soft
Tissue Release System | Comparison |
| Complies with ISO
10993-1 | Yes, complies with ISO 10993-
1:2018 | Yes, complies with ISO 10993-
1:2018 | Identical to
predicate device |
| Electrical Safety
Testing | N/A | N/A | Identical to
predicate device |
| Manufacturing | | | |
| Handpiece | Components machined both
internally and by external
suppliers. Anodized by external
supplier. Assembled, labeled, and
packaged internally. | Components machined both
internally and by external
suppliers. Anodized by external
supplier. Assembled, labeled, and
packaged internally. | Identical to
predicate device |
| Endoscope | Manufactured, labeled, and
packaged complete by external
supplier. | Manufactured, labeled, and
packaged complete by external
supplier. | Identical to
predicate device |
| Blade Assemblies | Components molded/
manufactured by external
suppliers. Assembled, packaged,
and labeled internally. Sterilized
by external supplier. | Components molded/
manufactured by external
suppliers. Assembled, packaged,
and labeled internally. Sterilized
by external supplier. | Identical to
predicate device |
| Sterilization Tray | Manufactured, labeled, and
packaged complete by external
supplier. | Manufactured, labeled, and
packaged complete by external
supplier. | Identical to
predicate device |
| Accessory
Instruments | Manufactured and labeled
complete by external supplier.
Packaged internally. | Manufactured and labeled
complete by external supplier.
Packaged internally. | Identical to
predicate device |
| Technological
Characteristic | SUBJECT
SmartRelease Endoscopic Soft
Tissue Release System | PREDICATE
510(K) K181819
SmartRelease Endoscopic Soft
Tissue Release System | Comparison |
| Packaging | | | |
| Reusable Devices | • Handpiece – placed in a Korrvu
insert (plastic film and
corrugated board), then placed
in corrugated shipper box.
• Endoscope – placed in a
custom-fit foam insert, then
placed in corrugated shipper
box.
• Sterilization Tray – shrink-
wrapped with plastic film, then
placed in corrugated shipper
box.
• Accessory Instruments – placed
in poly bags, heat-sealed on
both ends. | • Handpiece – placed in a Korrvu
insert (plastic film and
corrugated board), then placed
in corrugated shipper box.
• Endoscope – placed in a
custom-fit foam insert, then
placed in corrugated shipper
box.
• Sterilization Tray – shrink-
wrapped with plastic film, then
placed in corrugated shipper
box.
• Accessory Instruments – placed
in poly bags, heat-sealed on
both ends. | Identical to
predicate device |
| Sterile Devices
(blade assemblies) | Device placed in PETG Tray with
Tyvek lid, heat sealed on all four
sides. Tray placed in SBS box
(single- or 6-pack configuration). | Device placed in PETG Tray with
Tyvek lid, heat sealed on all four
sides. Tray placed in SBS box
(single- or 6-pack configuration). | Identical to
predicate device |
| Sterilization | | | |
| Sterilization | • Blade Assemblies are provided
sterile via gamma radiation, 25-
40kGy
• Handpiece, endoscope, and all
accessories are provided non-
sterile, to be cleaned and
sterilized via steam autoclave
by user prior to each use | • Blade Assemblies are provided
sterile via gamma radiation, 25-
40kGy
• Handpiece, endoscope, and all
accessories are provided non-
sterile, to be cleaned and
sterilized via steam autoclave
by user prior to each use | Identical to
predicate device |
6
7
8
Performance Data
As the subject device is identical in construction, geometry, functionality, and Intended Use to its cleared predicate, previous testing provided in the cleared K181819 demonstrates that the SmartRelease
9
Endoscopic Soft Tissue Release System is safe and effective for its Intended Use. Nothing has changed with the SmartRelease System to alter that conclusion.
Shelf life testing originally submitted in K181819 was based on product that had undergone accelerated aging conditioning. Since that submission was cleared, performance testing has been completed on product that has undergone real time aging to support the labeling shelf life. All products under consideration passed this testing.
A new User Validation was performed with appropriate users for the subject device's new Indication for Use to evaluate the user interfaces and to confirm that the intended user groups can appropriately use the device and demonstrate that the device is safe and effective for the new Indication for Use. Twenty users participated in cadaver labs with the subject device, walking through the procedure for trigger finger release on both fingers and thumbs on multiple hands each, for a total evaluation of 80 fingers and 40 thumbs. The results confirm that the SmartRelease Endoscopic Soft Tissue Release System 1) presents no usability risks, 2) can be safely and effectively used as intended, and 3) meets the User Needs.
Intended Use
The Intended Use is identical between the subject device and predicate. The addition of the "Trigger finger release in the hand" Indication for Use does not change the Intended Use nor raise any concerns regarding safety or effectiveness, as discussed above.
8. Statement of Substantial Equivalence
The subject device, SmartRelease Endoscopic Soft Tissue Release System, is the identical product as its predicate, cleared under K181819. It has the same technological characteristics, same performance testing and results, and the same Intended Use as its predicate. The added Indication for Use does not raise new or different questions of safety or effectiveness, as demonstrated in the User Validation. Therefore, the subject SmartRelease Endoscopic Soft Tissue Release System is substantially equivalent to the predicate device.
9. Referenced Standards
The SmartRelease Endoscopic Soft Tissue Release System also complies in whole or in part to the following consensus standards.
- ISO 14971:2019, Medical devices – Application of risk management to medical devices
- ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . ISO 15223-1:2021, Medical devices – Symbol to be used with information to be supplied by the manufacturer - Part 1: General requirements
- ISO 20417:2021, Medical devices – Information to be supplied by the manufacturer
10
- IEC 62366-1:2020, Medical devices – Part 1: Application of usability engineering to medical devices
- . ISO 11137-1:2006, Sterilization of health care products – Radiation – Part 1: Requirements for development validation and routine control of a sterilization process for medical devices
- . ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
- ISO 11607-1:2019, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials sterile barrier systems and packaging systems
- . ISO 11607-2:2019, Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming sealing and assembly processes
- . ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F2096-11, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ANSI AAMI ST77:2013/(R)2018, Containment devices for reusable medical device sterilization
- ANSI AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in ● health care facilities
10. Conclusion
SmartRelease Endoscopic Soft Tissue Release System is substantially equivalent to the predicate device in technical characteristics, design features, operating principles, functional and performance characteristics, and for the intended uses in the stated medical specialties. The SmartRelease Endoscopic Soft Tissue Release System is designed to comply with applicable federal safety and performance standards. The User Validation data support the new indication claim. There are no new safety and effectiveness issues.