(74 days)
Not Found
No
The summary describes a cryogenic surgical device that uses the Joule-Thomson effect and latent heat of vaporization for cooling. It mentions electrical nerve stimulation for location but does not include any language related to AI, ML, algorithms, or data processing for decision-making or analysis.
Yes
The device is described as being used to "destroy tissue during surgical procedures" and to "produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain." It is also indicated for "the relief of pain and symptoms associated with osteoarthritis of the knee." These applications are consistent with the definition and purpose of a therapeutic device.
No
The device is described as a "portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold." Its functions involve tissue destruction and pain relief, and while it can facilitate nerve location by conducting electrical stimulation, its primary purpose is therapeutic, not diagnostic.
No
The device description clearly outlines multiple hardware components including a Handpiece, Charging Dock, Smart Tips, and a Cartridge containing nitrous oxide. It is a physical device that uses cryotherapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "destroy tissue during surgical procedures by applying freezing cold" and "to produce lesions in peripheral nervous tissue... for the blocking of pain." It also mentions relief of pain and symptoms associated with osteoarthritis of the knee. These are all therapeutic or surgical interventions performed on the patient's body.
- Device Description: The description details a portable cryogenic surgical device that applies cold to tissue. It involves a handpiece, smart tips, and a cartridge containing nitrous oxide. These components are designed for direct application to the patient's body.
- Lack of In Vitro Activity: An IVD is a medical device intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such examination of specimens.
The device's function is to directly interact with and modify tissue within the patient's body, which is characteristic of a therapeutic or surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The iovera System is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera System is not indicated for treatment of central nervous system tissue.
When stimulation compatible components are used, the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.
Product codes
GXH, ETN
Device Description
The iovera? System is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera" System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.
The device comprises four main components:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient-use Smart Tips ●
- A Cartridge containing nitrous oxide ●
The iovera® System Handpiece is battery powered and provides feedback to the user during device preparation and use. The Handpiece connects to both the Cartridge and to the Smart Tip. The user activates a treatment cycle through a control on the Handpiece, which starts and stops the treatment. The Handpiece contains an LCD display for providing feedback to the user when the device is ready to use. The Charging Dock stores the Handpiece between uses and provides power for charging the battery.
An assortment of Smart Tips is available for the ioveraº system. All Smart Tip needles are made of stainless steel and have a closed-end design that fully contains the cryogen so that it does not enter the target tissue. The Smart Tip is the only patient contacting component of the iovera® System. The user removes the Smart Tip from its sterile packaging and attaches it to the Handpiece immediately before use. Certain Smart Tip designs provide a connection to an external nerve stimulator to facilitate nerve location prior to treatment.
The iovera System uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N20.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral nerves
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)
Design Verification testing was performed for the iovera System to demonstrate that the device meets product specifications for its intended clinical use. Using a risk-based approach for the modifications, design verification testing was performed according to recognized standards, and is consistent with the predicate device and test methods described in previous 510(k) submissions for the iovera system. The verification methods used and applied are appropriate for the changes. The verification and validation testing assures the modified subject device meet design input requirements, product specifications and relevant standards.
Key tests performed include:
- Functional and Product Performance Testing of the Handpiece and Cartridge
- Smart Tip Functional Testing
- User Interface Testing: IEC 62366-1:2015
- Software Testing: Conforms to IEC 62304:2006/A
- Electrical and EMC Safety Testing: Conforms to IEC-60601-1: A1 2012 and 60601-1-2:2014
- Mechanical and Thermal Safety Testing: Conforms to IEC 60601-1: A1:2012
- Sterility Testing: Conforms to ASTM F1980-16 and ISO 11135:2014/A
- Packaging Testing: Conforms to ASTM D4332-14.
- Biocompatibility Testing: Conforms to ISO 10993-1
Verification and validation testing performed on the subject device supports the substantial equivalence of the modified iovera System to the predicate device. The subject iovera System device met the design verification and validation inputs, passing all predetermined acceptance criteria. No new issues of safety or effectiveness were identified during design verification and validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ioveraº System K173763 and K211334
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4250 Cryogenic surgical device.
(a)
Identification. A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.(b)
Classification. Class II (performance standards).
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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2022
Pacira Biosciences, Inc. Danny Rivera Sr. Director, Quality and Regulatory Affairs 10450 Science Center Drive San Diego, California 92121
Re: K220656
Trade/Device Name: iovera System Regulation Number: 21 CFR 882.4250 Regulation Name: Cryogenic Surgical Device Regulatory Class: Class II Product Code: GXH, ETN Dated: April 20, 2022 Received: April 21, 2022
Dear Danny Rivera:
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 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,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220656
Device Name iovera® System
Indications for Use (Describe)
The iovera System is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera" System is not indicated for treatment of central nervous system tissue.
When stimulation compatible components are used , the iovera System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.
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) |
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3
510(k) SUMMARY
| Device Trade Name: | iovera º System |
|---|---|
| Device Common Name | Cryogenic Surgical Device |
| Device Class: | II |
| Classification Name: | Cryosurgical Unit and Accessories Device |
| Surgical Nerve Stimulator | |
| Regulation No.: | 21 CFR Part 882.4250 and 874.1820 |
| Product Code: | GXH, ETN |
| Predicate Device: | ioveraº System K173763 and K211334 |
| Owner/Submitter: | Pacira Biosciences, Inc. |
| 10450 Science Center Drive | |
| San Diego, California 92121 | |
| Regulatory Contact: | Danny Rivera |
| Senior Director, Quality and Regulatory Affairs | |
| Tel: 8586252414 Ext 3175 | |
| Email: Danny.Rivera@Pacira.com | |
| Date: | May 20, 2022 |
4
DEVICE DESCRIPTION
The iovera? System is a portable cryogenic surgical device used to destroy tissue and/or produce lesions in nervous tissue through application of extreme cold to the selected site. The device is based on introduction of a Smart Tip internally cooled by the cryogenic fluid (nitrous oxide, N2O) to a selected area. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization. The iovera" System may be used in conjunction with standard of-the-shelf nerve stimulator device in applications where precise nerve location is desired.
Device Design
The device comprises four main components:
- A reusable Handpiece
- A Charging Dock
- An assortment of single-patient-use Smart Tips ●
- A Cartridge containing nitrous oxide ●
The iovera® System Handpiece is battery powered and provides feedback to the user during device preparation and use. The Handpiece connects to both the Cartridge and to the Smart Tip. The user activates a treatment cycle through a control on the Handpiece, which starts and stops the treatment. The Handpiece contains an LCD display for providing feedback to the user when the device is ready to use. The Charging Dock stores the Handpiece between uses and provides power for charging the battery.
An assortment of Smart Tips is available for the ioveraº system. All Smart Tip needles are made of stainless steel and have a closed-end design that fully contains the cryogen so that it does not enter the target tissue. The Smart Tip is the only patient contacting component of the iovera® System. The user removes the Smart Tip from its sterile packaging and attaches it to the Handpiece immediately before use. Certain Smart Tip designs provide a connection to an external nerve stimulator to facilitate nerve location prior to treatment.
The iovera System uses a commercially available nitrous oxide cylinder. The Cartridge is filled with pure N20.
Device Functionality/Scientific Concepts:
The device functionality is based on the user introducing the Smart Tip into the selected treatment area or the target nervous tissue. The user then initiates the flow of cryogen by pressing the on/off button. Liquid cryogen flows from the Handpiece into the closed-end Smart Tip. The Smart Tip is cooled by the Joule-Thomson Effect and/or latent heat of vaporization; as the liquid cryogen expands into a gas, the temperature drops around the external surface of the Smart Tip, causing the surrounding tissue to freeze. The treatment is completed after a pre-programmed amount of time, at which time the user can safely remove the Smart Tip from the treatment site.
5
INTENDED USE/INDICATIONS FOR USE
The iovera? System is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The iovera® System is not indicated for treatment of central nervous system tissue.
When stimulation compatible components are used, the iovera? System can also facilitate target nerve location by conducting electrical nerve stimulation from a compatible 3rd party nerve stimulator.
SUMMARY/COMPARISON OF IOVERA® SYSTEM DEVICE CHARACTERISTICS
The iovera System is substantially equivalent in intended use, technology, design, and materials to the above listed legally marketed predicate devices.
| Parameter | Proposed
iovera o System | Predicate 1
iovera o System
K211334 | Predicate 2
iovera o System
K173763 |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Destroy tissue through
freezing | Same | Same |
| Indications for Use | The ioverao System is used
to destroy tissue during
surgical procedures by
applying freezing cold. It
can also be used to produce
lesions in peripheral nervous
tissue by the application of
cold to the selected site for
the blocking of pain. It is
also indicated for the relief
of pain and symptoms
associated with osteoarthritis
of the knee for up to 90
days. The ioverao system is
not indicated for treatment
of central nervous system
tissue.
When stimulation | The ioverao System is used to
destroy tissue during surgical
procedures by applying
freezing cold. It can also be
used to produce lesions in
peripheral nervous tissue by
the application of cold to the
selected site for the blocking
of pain. It is also indicated for
the relief of pain and
symptoms associated with
osteoarthritis of the knee for
up to 90 days. The ioverao
system is not indicated for
treatment of central nervous
system tissue. | The ioverao System is used to
destroy tissue during surgical
procedures by applying
freezing cold. It can also be
used to produce lesions in
peripheral nervous tissue by
the application of cold to the
selected site for the blocking
of pain. It is also indicated for
the relief of pain and
symptoms associated with
osteoarthritis of the knee for
up to 90 days. The ioverao
system is not indicated for
treatment of central nervous
system tissue.
The ioverao System's
"1x90" Smart Tip |
| | compatible components are
used, the ioverao System can
also facilitate target nerve
location by conducting
electrical nerve stimulation
from a 3rd party nerve
stimulator. | | configuration (indicating
one needle which is 90
mm long) can also
facilitate target nerve
location by conducting
electrical nerve
stimulation from a
separate nerve stimulator. |
| Anatomical Sites | Peripheral nerves | Same | Same |
| Parameter | Proposed
iovera o System | Predicate 1
iovera o System
K211334 | Predicate 2
iovera o System
K173763 |
| Technology | Cryogenic surgical device
with needle which
penetrates treatment area | Same | Same |
| Cryogen cartridge size | 21ml (14.3 gram fill)
nitrous oxide cartridge | Same | 10ml (7.5 gram fill) nitrous
oxide cartridge |
| Cryogen cartridge loading | Cartridge is loaded via a
hinged door on the side of
the device. Closing the
door provides the force
necessary to pierce the
cartridge. | Same | Cartridge is loaded from the
back of the device. Screwing
on the cap provides the force
necessary to pierce the
cartridge. |
| Cryogen cartridge
piercing point/filter | In-line piercing point and
filter assembly resides in a
replaceable assembly
within the device. | Same | In-line piercing point and
filter are part of cryogen
cartridge assembly. |
| Human Factors | Hand-held device containing
cryogen. Detachable
cryoprobes (Smart Tips). | Same | Same |
| Information display | Color graphic LCD on rear
of device. Additional
information regarding
failure mode is also | Same | Array of different colored
LEDs located around the
device. |
| Charging Dock display | LED light bar indicating
Charging Dock is receiving
power from AC-DC
adapter. Light bar changes
color when Charging Dock
is supply charging current
to Handpiece. | Same | LED indicating Charging
Dock is receiving power
from AC-DC adapter. |
| Digital Interfaces | USB and SD card. The SD
card is not part of the
product offering to the
customer. This tool is used
for troubleshooting during
in-house failure
investigation. The SD card
has no impact on | Same | USB |
| Method of Smart Tip
attachment | Push-on/pull-off design | Same | Screw-on tip attachment |
| Skin-warmer heating | Semiconductor device used
as heating element - this
element is thermally
connected to heating block
and monitored with
redundant thermistors. | Same | Resistors used as heating
element - this element is
thermally connected to
heating block and monitored
with redundant thermistors. |
| Parameter | Proposed
iovera® System | Predicate 1
iovera® System
K211334 | Predicate 2
iovera® System
K173763 |
| Cryogen valve | Valve comprises needle
valve in compliant sealing
element.
Valve is controlled by
stepper-motor-based linear
actuator.
Switch detects valve open
position. | Same | Valve comprises face-to-
face seal against compliant
sealing element.
Valve is controlled by
stepper-motor-based linear
actuator. |
| Power Source | Battery powered
Battery type: Single cell
Lithium Ion, 3100mAh
Battery voltage: 3.6Volts
Main powered Charging
Dock | Same | Same |
| Operating Principle | Joule-Thomson Effect/
Latent Heat of
Vaporization | Same | Same |
| Needle Size | 20G, 27G | Same | 20G |
| Catalog Numbers | STT2309, STT2190, and
STT2190STIM | STT2309 and STT2190 | STT0811 |
| Needle Working Length | 8.5mm, 90mm | Same | 90mm length |
| Needles/Tip | 1 x 20G (90mm)
3 x 27G (8.5mm) | Same | 1 x 20G (90mm) |
| Nerve Stimulation Support | Yes¹ | N/A | Yes |
| Pre-heat time (min) | 12 seconds (8.5mm)
1 second (90mm) | Same | 1 second (90mm) |
| Cooling Time (max) | 33 seconds (8.5mm)
60 seconds (90mm) | Same | 60 seconds (90mm) |
| Post -heat Time | 20 seconds (8.5mm)
45 seconds (90mm) | Same | 45 seconds (90mm) |
| Skin Warmer Set Point | 30°C | Same | Same |
| Clinical Effect | Cellular death through
cryoneurolysis and
Wallerian degeneration
Second degree nerve
injury (axonotmesis) | Same | Same |
| Treatment Temperature | -55° C to -75°C (-67°F to -
103°F) | Same | Same |
| Parameter | Proposed
iovera o System | Predicate 1
iovera o System
K211334 | Predicate 2
iovera o System
K173763 |
| Treatment Time | Preprogrammed into the
smart tip. | Same | Same |
| Treatment Options | Multiple Smart Tip
options are available for
producing different
cryozone (ice ball) sizes. | Same | Same |
| Single-patient Use | Smart Tips are single-patient
use. Handpiece is reusable. | Same | Same |
| Sterility Assurance Level | Smart Tip individually
packaged and sterile with
a SAL of 10-6. | Same | Same |
| Shelf Life | 37-month | Same | Same |
| Biocompatible | Biocompatible. All patient
contacting materials, tested
to ISO 10993-1 | Same | Same |
Substantial Equivalence Comparison Table
6
7
4 Nerve-stim tips have a thin, electrically insulating coating (Parylene C) over most of the needle and include an electrical connection between the needle and an external, off-the-shelf PENS device. All other aspects of the design are identical to the non-nerve-stim version of the tip.
8
SUMMARY OF PERFORMANCE TESTING
Design Verification testing was performed for the ioveras System to demonstrate that the device meets product specifications for its intended clinical use. Using a risk-based approach for the modifications, design verification testing was performed according to recognized standards, and is consistent with the predicate device and test methods described in previous 510(k) submissions for the iovera system. The verification methods used and applied are appropriate for the changes. The verification and validation testing assures the modified subject device meet design input requirements, product specifications and relevant standards.
- Functional and Product Performance Testing of the Handpiece and Cartridge
- Smart Tip Functional Testing
- User Interface Testing: IEC 62366-1:2015 ●
- Software Testing: Conforms to IEC 62304:2006/A ●
- Electrical and EMC Safety Testing: Conforms to IEC-60601-1: A1 2012 and 60601-1-2:2014 ●
- Mechanical and Thermal Safety Testing: Conforms to IEC 60601-1: A1:2012 ●
- Sterility Testing: Conforms to ASTM F1980-16 and ISO 11135:2014/A ●
- Packaging Testing: Conforms to ASTM D4332-14. ●
- Biocompatibility Testing: Conforms to ISO 10993-1 ●
Verification and validation testing performed on the subject device supports the substantial equivalence of the modified ioveraº System to the predicate device. The subject ioveraº System device met the design verification and validation inputs, passing all predetermined acceptance criteria. No new issues of safety or effectiveness were identified during design verification and validation testing.
9
CONCLUSION
The subject ioveraº System, with the same intended use, indications for use, design, materials, technological features, and principles of operation as the cleared ioveraº Systems (K211334 and K173763), is substantially equivalent to these predicate devices. The modification to the Indications for Use proposed in this 510(k) does not affect the safety and effectiveness of the device as the intended therapeutic use for the creation of lesions with the application of cold in peripheral nerves to block pain has not changed.
The modification described, and the information presented, in this special premarket notification demonstrates that ioveraº System is safe and effective, does not introduce or raise new questions of safety and effectiveness, and is substantially equivalent in intended use, technology, design, and materials to the legally marketed predicate devices.