← Product Code [OMP](/productcode/OMP) · K212359 # PWD Negative Pressure Wound Therapy System (K212359) _Applied Tissue Technologies, LLC · OMP · Sep 21, 2022 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K212359 ## Device Facts - **Applicant:** Applied Tissue Technologies, LLC - **Product Code:** [OMP](/productcode/OMP.md) - **Decision Date:** Sep 21, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4780 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Applied Tissue Technologies PWD™ Platform Wound Dressing Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies), flaps, grafts and closed surgical incisions. PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting. ## Device Story System provides negative pressure wound therapy (NPWT) to promote healing in a moist environment. Inputs: wound exudate drawn through dressing access port. Operation: microprocessor-controlled pump applies fixed -80 mmHg negative pressure to wound bed; exudate collected in external canister. Used in hospital or home settings by clinicians or patients. Output: negative pressure therapy and fluid removal. Benefits: promotes healing by removing excess exudate and maintaining wound environment. Healthcare providers use system to manage various wound types; output (exudate removal) informs wound management progress. ## Clinical Evidence Bench testing only. Evaluated vapor transmission (ASTM 1249), exudate throughput, negative pressure maintenance, usability, electrical safety (IEC 60601-1, 1-2, 1-11), and EMC (IEC 60601-2-3). Biocompatibility testing performed per ISO 10993. All tests passed. ## Technological Characteristics System includes polyurethane dressing, microprocessor-controlled pump, and exudate canister. Fixed -80 mmHg pressure. Dressing supplied sterile (EtO, SAL 10^-6); pump/canister non-sterile. Connectivity: standalone. Electrical safety: IEC 60601-1, 1-2, 1-11. EMC: IEC 60601-2-3. MR Unsafe. ## Regulatory Identification A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter. ## Predicate Devices - PICO 7 Single Use Negative Pressure Wound Therapy System ([K172005](/device/K172005.md)) - PWD™ Platform Wound Device ([K191460](/device/K191460.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words. September 21, 2022 Applied Tissue Technologies LLC % Ms. Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye HIll Landing Newbury, New Hampshire 03255 Re: K212359 Trade/Device Name: PWD Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 19, 2022 Received: August 23, 2022 Dear Ms. Lucey: 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 {1}------------------------------------------------ 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 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, for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K212359 Device Name PWD™ Platform Wound Dressing Negative Pressure System Indications for Use (Describe) The Applied Tissue Technologies PWD™ Platform Wound Dressing Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies), flaps, grafts and closed surgical incisions. PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting. | 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}------------------------------------------------ ## K212359 Traditional 510(k) SUMMARY #### Submitter Information | Submitters' Name: | Applied Tissue Technologies LLC | |------------------------------|---------------------------------------------------------------------| | Address: | 99 Derby Street, Suite 200 | | | Hingham, MA 02043 | | Telephone: | 781-366-3848 | | Contact Person: | Ms. Michele Lucey | | | President, Lakeshore Medical Device Consulting LLC | | Address | 128 Blye Hill Landing, | | | Newbury, NH 03255 | | Telephone | 603-748-1374 | | Email | lucey_m@msn.com | | Date Prepared: | September 20, 2022 | | Device Trade Name: | PWD™ Platform Wound Dressing Negative Pressure
System | | Classification: | Class II | | Product Code(s): | OMP | | Regulation Number(s): | 21 CFR 878-4780 Powered Suction Pump | | Predicate Device (Primary): | PICO 7 Single Use Negative Pressure
Wound Therapy System K172005 | | Predicate Device (Secondary) | PWD™ Platform Wound Device K191460 | #### Indications for Use: The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, {4}------------------------------------------------ #### K212359 traumatic, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies). flaps, grafts and closed surgical incisions. PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting. ### Device Description/Technological Characteristics: The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System consists of the PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump and the Wound exudate canister. The system provides a negative pressure wound dressing therapy in a moist environment to facilitate the wound healing process. The dressing has an access port through which fluids can be drawn from the wound site. The same port can also be utilized to administer negative pressure wound therapy using the negative pressure pump if required. The negative pressure pump is used with a collection cannister to collect the exudate. The PWD Platform Wound Dressing is supplied in five different shapes and sizes, all having the same intended use. The five sizes are identified as follows. | PWD TM Platform Wound Device Dressing Sizes | | |-------------------------------------------------|---------------| | Description | Catalog/REF # | | 1" Round | AT1070-01 | | 2" Round | AT1071-01 | | 3" Round | AT1072-01 | | 1" x 3" Oblong | AT1073-01 | | 3" x 5" Oblong | AT1074-01 | #### Performance Data: Bench testing of the PWD™ Platform Wound Dressing Negative Pressure System was performed to evaluate device vapor transmission characteristics, ability to maintain negative pressure, and the ability to remove exudate. Biocompatibility testing was conducted on the dressing component according to the ISO 10993 standard series. The Pump and the Cannister are not tissue contacting. Test results of all nonclinical testing were acceptable and demonstrate that the device is safe and effective for its intended use. A summary of the Non-clinical Bench tests is provided in the following Table: | Performance Test Summary | | | | | |-------------------------------------|---------------------------------------------------------------------------------------|------------------------|---------------------------------------------------------------------------------|---------| | Test Name | Description | Reference
Standards | Acceptance Criteria | Results | | Water Vapor
Transmission
Rate | Measures the
passage of water
vapor through the
membrane/adhesive
barrier | ASTM 1249 | Must be at least
equivalent to
commercially
available NPWT
dressing | Pass | | Exudate | Simulated Use | N/A | System must | Pass | {5}------------------------------------------------ | Performance Test Summary | | | | | |-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------| | Test Name | Description | Reference
Standards | Acceptance Criteria | Results | | Throughput
Properties
Under
Negative
Pressure | testing using various
exudate types to
confirm acceptable
fluid flow when
connected to the
Pump and Canister
system | | demonstrate the
ability to remove
exudates of various
types from the wound
bed | | | Maintenance of
Negative
Pressure | Simulated use testing
from under moist
conditions to
demonstrate
maintenance of
negative pressure | NA | The PWD must
maintain negative
pressure at the wound
bed for the test
duration | Pass | | Usability | Usability testing for
both health care and
home use
environments | NA | Users must
demonstrate the
ability to correctly use
the device | Pass | | Electrical
Safety | Complies with
applicable safety
standards | IEC 60601-
1, IEC
60601-1-2,
IEC 60601-
1-11 | Requirements for
electrical safety per
the applicable safety
standards is met | Pass | | Electro-
magnetic
Compatibility | Complies with
applicable safety
standards | Complies
with IEC
60601-2-3 | Requirements for
electromagnetic
compatibility per the
applicable safety
standards is met | Pass | # Substantial Equivalence: The Indications for Use statement for the PWD™ Platform Wound Dressing Negative Pressure System is the same as the PICO 7 Single Use Negative Pressure Wound Therapy System. The following table provides the evidence to further support the claim for substantial equivalence: {6}------------------------------------------------ | Substantial Equivalence Comparison Chart | | | | | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Feature /
Specification | PWD™ Platform
Wound Dressing
Negative Pressure
System | PICO 7 Single
Use Negative
Pressure Wound
Therapy System | PWDTM
Platform Wound
Dressing | Comparison | | Regulatory
Clearance/
Approval
Reference | N/A | Primary
K172005 | Secondary
K191460 | N/A | | Product Code | OMP | OMP | OMP | Same | | Regulation
Number | 21 CFR 878.4780 | 21 CFR
878.4780 | 21 CFR 878.4780 | Same | | Regulation Name | Powered Suction
Pump | Powered Suction
Pump | Powered Suction
Pump | Same | | Anatomical
location | Body surface where
wound is present | Body surface where
wound is present | Body surface
where wound is
present | Same | | Where used
(environment) | The Negative Pressure
Wound Therapy System
is suitable for use in
both hospital and
homecare
settings. | The Negative
Pressure Wound
Therapy System is
suitable for use in
both hospital
and homecare
settings. | The Negative
Pressure Wound
Therapy System is
suitable for use in
both hospital and
homecare settings. | Same | | Indications
for Use | The Applied Tissue
Technologies PWD™
Platform Wound
Dressing Negative
Pressure System
comprised of the;
PWD™ Dressing,
PWD™ Negative
Pressure Wound
Therapy Pump, and the
PWD™ Wound
Exudate Canister is
indicated in patients
who would benefit from
a suction device
(Negative Pressure
Wound Therapy) as it
creates an environment
that may promote
wound healing by
removing excess wound | PICO 7 is
indicated for
patients who would
benefit from a
suction device
(Negative Pressure
Wound Therapy) as
it may promote
wound healing via
removal of low to
moderate levels of
exudate and
infectious
materials.
Appropriate wound
types include:
Chronic
Acute
Traumatic
Subacute and
dehisced wounds | The Applied
Tissue
Technologies
PWDTM Platform
Wound Dressing is
intended to be
used in
conjunction with
the Invia Motion
Negative Pressure
Wound Therapy
(NPWT) system
and is indicated in
patients who
would benefit
from a suction
device (NPWT) as
it creates an
environment that
may promote
wound healing by | | {7}------------------------------------------------ | Substantial Equivalence Comparison Chart | | | | | | | | |-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--|--|--| | Feature /
Specification | PWD™ Platform
Wound Dressing
Negative Pressure
System | PICO 7 Single
Use Negative
Pressure Wound
Therapy System | PWDTM
Platform Wound
Dressing | Comparison | | | | | | exudate. The Applied
Tissue Technologies
Platform Wound
Dressing is appropriate
for use on the following
wounds: exudating,
chronic, acute,
traumatic, sub-acute
and dehisced wounds,
partial thickness burns,
ulcers (such as diabetic,
pressure and venous
insufficiencies), flaps,
grafts and closed
surgical incisions.
PWD Negative
Pressure Wound
Therapy System are
suitable for use both in
a hospital and homecare
setting. | Partial-thickness
burns, Ulcers (such
as diabetic or
pressure)
Flaps and grafts
Closed surgical
incisions
PICO Single Use
Negative Pressure
Wound Therapy
System is suitable
for use
in both a hospital
and homecare
setting. | removing excess
wound exudate.
The Applied
Tissue
Technologies
Platform Wound
Dressing is
appropriate for
use on the
following
wounds:
exudating,
chronic, acute,
traumatic, sub-
acute and
dehisced wounds,
partial-thickness
burns, ulcers
(such as: diabetic,
pressure and
venous
insufficiencies),
flaps and grafts | | | | | | Maximum
Duration of
a single dressing | 7 Days | 7 Days | 3 Days | Same as the
primary
predicate | | | | | Negative
Pressure to the
wound surface
requirements in
mmHg | Fixed setting at -80
mmHg (nominal) to the
wound surface | Fixed setting at -80
mmHg to the wound
surface | -80 mmHg | Same | | | | | Multiple Dressing
Shapes for Wound
Sizes (area = L x
W) | 1-3" Round
1 x 3" Oblong
3 x 5" Oblong | 10 x 20 cm to 25 x
25 cm | 1-3" Round
1 x 3" Oblong
3 x 5" Oblong | PWD is
smaller than
the predicate
for overall
dimensions.
The dressing
is sized for
the wound | | | | {8}------------------------------------------------ | Substantial Equivalence Comparison Chart | | | | | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Feature /
Specification | PWD™ Platform
Wound Dressing
Negative Pressure
System | PICO 7 Single
Use Negative
Pressure Wound
Therapy System | PWD™
Platform Wound
Dressing | Comparison | | | | | | size. Same as
the Secondary
Predicate | | Dressing
Configura
tion | Clear polyurethane
embossed occlusive
drape with negative
pressure/instillation
tubing | Clear polyurethane
occlusive drape
dressing with foam
or gauze filler,
negative
pressure/instillation
tubing - filler is cut
to size | Clear
polyurethane
embossed
occlusive drape
with negative
pressure/instillat
ion tubing | Same as the
secondary
predicate | | Access Port | For attachment to the
negative pressure pump.
For removal of fluids. | For attachment to the
negative pressure
pump. For removal
of fluids | For attachment to
the negative
pressure pump.
For removal of
fluids. | Same | | Collection Pack | The dressing tubing is
connected to the
canister/tubing set
during negative pressure
wound therapy for
collection of fluids. The
fluids are removed from
the wound site and
secured within the
cannister without
requiring additional
dressing changes | No Cannister, relies
on dressing changes
for removal of
exudate, frequency
dependent on the
level of exudate | The dressing
tubing is
connected to the
canister/tubing set
during negative
pressure wound
therapy for
collection of
fluids. The fluids
are removed from
the wound site
and secured
within the
cannister without
requiring
additional
dressing changes | Same as the
secondary
predicate. | | Pump | PWD™ Negative
Pressure Wound
Therapy Pump | PICO 7 | NA | Same | | Pump Type | Custom designed pump
controlled by a
microprocessor | Custom designed
pump controlled by
a microprocessor | NA | Same | {9}------------------------------------------------ | Substantial Equivalence Comparison Chart | | | | | | | | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--| | Feature /
Specification | PWD™ Platform
Wound Dressing
Negative Pressure
System | PICO 7 Single
Use Negative
Pressure Wound
Therapy System | PWD™
Platform Wound
Dressing | Comparison | | | | | How Supplied | PWD Dressing is
supplied Sterile Single
Use Only. The pump
and cannister are
supplied non-sterile
single use only | The system is
supplied sterile,
single use only | PWD Dressing is
supplied Sterile
Single Use Only. | The PWD
pump and
cannister are
supplied
nonsterile –
similar to
other systems
with the same
intended use.
This
difference
does not raise
new questions
of safety. | | | | | Tissue
Contact
Materials | Polymers and Adhesive | Polymers and
Adhesive | Polymers and
Adhesive | Same as the
secondary
predicate | | | | | Additives -
antimicrobial,
animal origin | No | No | No | Same | | | | | Sterilization | Eto at an SAL 10-6 | Eto | Eto at an SAL 10-6 | Same. | | | | | Electrical Safety
Testing | Complies with IEC
60601-1, IEC 60601-1-
2, IEC 60601-1-11 | Complies with IEC
60601-1, IEC 60601-
1-2, IEC 60601-1-11 | NA | Same | | | | | Electromagnetic
Compatibility | Complies with IEC
60601-2-3 | Complies with IEC
60601-2-3 | NA | Same | | | | | MR Safety | Pump is MR Unsafe | Pump is MR Unsafe | NA | Same | | | | ## Conclusion: When considering design, feature, materials, and performance characteristics the PWD™ PNegPlatform Wound Dressing Negative Pressure System is substantially equivalent to the predicate device, the PICO 7 Single Use Negative Pressure Wound Therapy System K172005 --- **Source:** [https://fda-staging.innolitics.com/device/K212359](https://fda-staging.innolitics.com/device/K212359) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com