(242 days)
No
The document describes a sterile NPWT dressing and associated components, focusing on mechanical function and compatibility with existing NPWT pumps. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for promoting wound healing, reducing edema, promoting granulation tissue formation, and removing exudate and infectious material, all of which are considered therapeutic actions.
No
The device, "The Invia Integrated Dressing," is described as a sterile Negative Pressure Wound Therapy (NPWT) dressing intended to promote wound healing and manage surgical incisions by removing exudate and infectious material. Its function is to treat existing conditions, not to identify or diagnose them.
No
The device description explicitly details physical components like a pad area, adhesive wound contact layer, and tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Invia Integrated Dressing is a component of a Negative Pressure Wound Therapy (NPWT) system. Its function is to apply negative pressure to a wound to promote healing by removing exudate, reducing edema, and creating an environment conducive to tissue growth.
- Intended Use: The intended use clearly describes the device's application directly to wounds (open or closed surgical incisions) on the patient's body. It does not involve testing samples taken from the body.
The device is a therapeutic device used for wound management, not a diagnostic device used for testing bodily samples.
N/A
Intended Use / Indications for Use
The Invia® Integrated Dressing in conjunction with the Invia NPWT Systems is indicated for patients who would benefit from a suction device (NPWT) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
When used on closed surgical incisions, the Invia Integrated Dressing is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Integrated Dressing is appropriate for the following indications:
- Acute or sub-acute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Invia Integrated Dressing is a sterile NPWT dressing, consisting of: a pad area designed to evenly distribute the negative pressure and to draw off the exudate, a perforated silicone adhesive wound contact layer to provide a gentle but secure adhesion to the skin, and a double lumen tubing with Quick-connector to connect the dressing to the Invia NPWT pumps.
The Invia Integrated Dressing is available in three different sizes as shown below.
| Description | Invia® Integrated Dressing | |||
|---|---|---|---|---|
| REF (model number) | 101035697 | 101035698 | 101035699 | |
| Pad area size | 10cm x 10cm | 10cm x 15cm | 10cm x 25cm | |
| Dressing Size | 18cm x 18cm | 18cm x 23cm | 18cm x 33cm |
Table 5-1: Invia Integrated Dressing covered by this 510(k)
The Invia Integrated Dressing is designed to be compatible with the Invia Negative Pressure Wound Therapy Systems (Invia® Liberty NPWT suction pump, cleared via K142626 and K172145) and Invia® Motion (cleared via K161128 and K172145) and Invia® Ease suction pumps (K214112).
For wounds greater than 0.5 cm in depth, it is likely that a wound filler needs to be used with the Invia Integrated Dressing to ensure adequate treatment of all the wound surfaces. The Invia Integrated Dressing can be used with the wound filler accessory, Invia Black Foam NPWT. The Invia Black Foam NPWT is available in one size as shown below.
Table 5-2: Invia Black Foam NPWT model covered by this 510(k)
| Description | Invia® Black Foam NPWT |
|---|---|
| REF (model number) | 101035701 |
| Foam pad size | 10 x 8 x 3 cm |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (Acute or sub-acute, Chronic, Dehisced, Pressure ulcers, Diabetic/neuropathic ulcers, Venous insufficiency ulcers, Traumatic, Partial thickness burns, Flaps and grafts, Closed surgical incisions)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospital and home
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)
Comparison of Technological Characteristics: Demonstrated equivalent intended use, indications for use, and fundamental technology.
Non-Clinical Tests:
- Risk analysis in accordance with ISO 14971:2019.
- Sterilization information in accordance with FDA Guidance (January 2016).
- Biocompatibility evaluation according to FDA Guidance (Sept. 2020), categorizing device for prolonged contact with breached or compromised surfaces. Evaluated endpoints: Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Systemic toxicity (acute), Pyrogenicity, and Subchronic toxicity (subacute toxicity).
- Summative human factors study performed according to FDA Guidance (February 03, 2016), demonstrated safe and effective use by lay users without preventable use errors.
- Bench testing: Conducted to check specifications and demonstrate performance equivalence to predicate Invia® Foam Dressing Kit with FitPad. Verification and validation tests executed for the subject device in combination with Medela Invia NPWT Systems (Invia® Liberty, Invia® Motion, Invia Ease) and various wound fillers (Invia® Black Foam NPWT, predicate black foam, Invia® White Foam, and gauze from Invia® Gauze Dressing Kit).
- Animal Testing: Demonstrated the subject device can be left in place for up to 7 days without adverse local tissue reactions (macroscopically or histopathologically). Complied with OECD Principles of Good Laboratory Practice.
Clinical Tests: Not required.
Key Results: Nonclinical testing concluded that the Invia® Integrated Dressing is substantially equivalent to the legally marketed predicate device, with no new intended use or different questions of safety and effectiveness introduced.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
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.(b)
Classification. Class II.
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
July 7, 2023
Medela AG % Adrienne Lenz Principal Medical Device Regulatory Expert Hyman, Phelps, & McNamara 700 Thirteenth Street, N.W. Washington, District of Columbia 20005
Re: K223388
Trade/Device Name: Invia® Integrated Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: June 6, 2023 Received: June 6, 2023
Dear Adrienne Lenz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Julie A. Morabito -S
Julie A. Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223388
Device Name Invia ® Integrated Dressing
Indications for Use (Describe)
The Invia® Integrated Dressing in conjunction with the Invia NPWT Systems is indicated for patients who would benefit from a suction device (NPWT) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
When used on closed surgical incisions, the Invia Integrated Dressing is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Integrated Dressing is appropriate for the following indications:
- Acute or sub-acute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
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
K223388
510(k) Summary Information
In accordance with 21 C.F.R. §807.92(a) the following summary of information is provided:
| Date Summary Prepared: | July 7, 2023 |
|---|---|
| Submitter/Applicant: | Medela AG |
| Lättichstrasse 4b | |
| CH 6340 Baar | |
| Switzerland | |
| Phone: +41 41 562 51 51 | |
| Fax: +41 41 562 51 00 | |
| Primary Contact Person: | Adrienne Lenz |
| Principal Medical Device Regulatory Expert | |
| Hyman, Phelps & McNamara P.C. | |
| Phone: (202) 737-4292 | |
| Email: ALenz@hpm.com | |
| Device Information | Trade/Device Name: Invia® Integrated Dressing |
| Regulation Name: Powered suction pump | |
| Regulation Number: 21 C.F.R. § 878.4780 | |
| Common Name: Negative Pressure Wound Therapy | |
| System | |
| Device Classification Name: Powered suction pump | |
| Product Code: OMP | |
| Regulatory Class: II | |
| Review Panel: General & Plastic Surgery | |
| Predicate Device Information | Invia Foam Dressing Kits With FitPad |
| K172145 | |
| Manufacturer: Medela AG | |
| Reference Device Information | PICO 7 Single Use Negative Pressure Wound Therapy |
| System | |
| K202157 | |
| Manufacturer: Smith & Nephew Medical Limited |
4
Device Description
The Invia Integrated Dressing is a sterile NPWT dressing, consisting of: a pad area designed to evenly distribute the negative pressure and to draw off the exudate, a perforated silicone adhesive wound contact layer to provide a gentle but secure adhesion to the skin, and a double lumen tubing with Quick-connector to connect the dressing to the Invia NPWT pumps.
The Invia Integrated Dressing is available in three different sizes as shown below.
| Description | Invia® Integrated Dressing | |||
|---|---|---|---|---|
| REF (model | ||||
| number) | 101035697 | 101035698 | 101035699 | |
| Pad area size | 10cm x 10cm | 10cm x 15cm | 10cm x 25cm | |
| Dressing Size | 18cm x 18cm | 18cm x 23cm | 18cm x 33cm |
Table 5-1: Invia Integrated Dressing covered by this 510(k)
The Invia Integrated Dressing is designed to be compatible with the Invia Negative Pressure Wound Therapy Systems (Invia® Liberty NPWT suction pump, cleared via K142626 and K172145) and Invia® Motion (cleared via K161128 and K172145) and Invia® Ease suction pumps (K214112).
For wounds greater than 0.5 cm in depth, it is likely that a wound filler needs to be used with the Invia Integrated Dressing to ensure adequate treatment of all the wound surfaces. The Invia Integrated Dressing can be used with the wound filler accessory, Invia Black Foam NPWT. The Invia Black Foam NPWT is available in one size as shown below.
Table 5-2: Invia Black Foam NPWT model covered by this 510(k)
| Description | Invia® Black Foam NPWT |
|---|---|
| REF (model number) | 101035701 |
| Foam pad size | 10 x 8 x 3 cm |
Indications for Use
The Invia Integrated Dressing in conjunction with the Invia NPWT Systems is indicated for patients who would benefit from a suction device (NPWT) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.
When used on closed surgical incisions, the Invia Integrated Dressing is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.
The Invia Integrated Dressing is appropriate for the following indications:
- Acute or sub-acute wounds 트
- 트 Chronic wounds
5
- Dehisced wounds ■
- י Pressure ulcers
- י Diabetic/neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns ■
- Flaps and grafts
- Closed surgical incisions
Comparison of Technological Characteristics
Invia® Integrated Dressing has same intended use, same indications for use, and has equivalent fundamental technology as the legally marketed predicate device to which substantial equivalency is claimed.
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Characteristics | Invia | ||
| Dressing | |||
| Integrated | Invia Foam Dressing Kit | ||
| with FitPad (K172145) | PICO 7 (K202157) | ||
| Product code | OMP | OMP | OMP |
| Intended Use | Dressing for Negative | ||
| Pressure Wound Therapy | Dressing for Negative | ||
| Pressure Wound Therapy | Dressing for negative | ||
| pressure wound therapy. | |||
| Indication for use | The Invia Integrated Dressing | ||
| in conjunction with the Invia | |||
| NPWT Systems is indicated | |||
| for patients who would | |||
| benefit from a suction device | |||
| (NPWT) as when used on | |||
| open wounds it creates an | |||
| environment that promotes | |||
| wound healing by secondary | |||
| or tertiary (delayed primary) | |||
| intention by preparing the | |||
| wound bed for closure, | |||
| reducing edema, promoting | |||
| granulation tissue formation | |||
| and perfusion, and by | |||
| removing exudate and | |||
| infectious material. | |||
| When used on closed surgical | |||
| incisions, the Invia Integrated | |||
| Dressing is also intended to | |||
| manage the environment of | |||
| surgical incisions that | |||
| continue to drain following | |||
| sutured or stapled closure by | The Invia Foam Dressing Kit | ||
| with FitPad in conjunction | |||
| with the Invia Motion and | |||
| Invia Liberty Negative | |||
| Pressure Wound Therapy | |||
| (NPWT) Systems is | |||
| indicated for patients who | |||
| would benefit from a suction | |||
| device (Negative Pressure | |||
| Wound Therapy) as when | |||
| used on open wounds it | |||
| creates an environment that | |||
| promotes wound healing by | |||
| secondary or tertiary | |||
| (delayed primary) intention | |||
| by preparing the wound bed | |||
| for closure, reducing edema, | |||
| promoting granulation tissue | |||
| formation and perfusion, and | |||
| by removing exudate and | |||
| infectious material. | |||
| When used on closed | |||
| surgical incisions, the Invia | |||
| Foam Dressing Kit with | |||
| FitPad is also intended to | |||
| manage the environment of | |||
| surgical incisions that | PICO 7 is indicated for | ||
| patients who would benefit | |||
| from a suction device | |||
| (NPWT) 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 - Partial-thickness burns
- Ulcers (such as diabetic
or pressure) - Flaps and grafts
- Closed Surgical
incisions
PICO 7 Single Use Negative
Pressure Wound Therapy
System is suitable for use |
6
| Characteristics | Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|---|
| Invia | ||||
| Dressing | Integrated | Invia Foam Dressing Kit | ||
| with FitPad (K172145) | PICO 7 (K202157) | |||
| maintaining a closed | ||||
| environment and removing | ||||
| exudate via the application of | ||||
| Negative Pressure Wound | ||||
| Therapy. | continue to drain following | |||
| sutured or stapled closure by | ||||
| maintaining a closed | ||||
| environment and | ||||
| removing exudates via the | ||||
| application of Negative | ||||
| Pressure Wound Therapy. | both in a hospital and | |||
| homecare setting. | ||||
| The Invia Integrated Dressing | ||||
| is appropriate for use for the | ||||
| following indications: |
- Acute or sub-acute
wounds - Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/neuropathic
ulcers - Venous insufficiency
ulcers - Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions | | The Invia Foam Dressing Kit
with FitPad is appropriate
for use for the following
indications: - Acute or sub-acute
wounds - Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/neuropathic
ulcers - Venous insufficiency
ulcers - Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical
incisions | |
| Contraindications | The Invia Integrated Dressing
has the following
contraindications: | | The Invia Foam Dressing Kit
with FitPad has the
following contraindications: | Pico 7 is contraindicated for: |
| | - Necrotic tissue with
eschar present - Untreated osteomyelitis
- Non-enteric and
unexplored fistulas - Malignancy in wound
(with exception of
palliative care to enhance
quality of life) - Exposed vasculature
- Exposed nerves
- Exposed anastomotic site
of blood vessels or
bypasses - Exposed organs | | - Necrotic tissue with
eschar present - Untreated osteomyelitis
- Non-enteric and
unexplored fistulas - Malignancy in the
wound - Exposed vasculature
- Exposed nerves
- Exposed anastomotic
site of blood vessels or
bypasses - Exposed organs | - Patients with
malignancy in the
wound bed or margins
of the wound (except in
palliative care to
enhance quality of life). - Previously confirmed
and untreated
osteomyelitis. - Non-enteric und
unexplored fistulas. - Necrotic tissue with
eschar present. - Exposed arteries, veins,
nerves or organs. - Exposed anastomic
sites. |
| | | | | PICO 7 should not be used
for the purpose of: |
| | | | | - Emergency airway
aspiration |
| | Subject Device | Predicate Device | Reference Device | |
| Characteristics | Invia
Dressing
Integrated | Invia Foam Dressing Kit
with FitPad (K172145) | PICO 7 (K202157) | |
| | | | Pleural, mediastinal or
chest tube drainage
Surgical suction | |
| Patient
population | Adults | Adults | Adults | |
| Use environment | Hospital and home | Hospital and home | Hospital and home | |
| Model number | Art.No 101035697
Art.No 101035698
Art.No 101035699 | Art.No. 087.6221(3 pcs)
Art.No 087.6222(3 pcs)
Art.No 087.6223(3 pcs)
Art.No 087.6224(3 pcs)
Art.No 087.6225(15 pcs)
Art.No 087.6226(15 pcs)
Art.No 087.6227(15 pcs) | Art.no 66802007 | |
| Dimensions
specifications
(Length x Width) | Small: 18cm x 18cm
Medium: 18cm x 23cm
Large: 18cm x 33cm | Small: 10cm x 8cm
Medium: 19cm x 12.5cm
Large: 25cm x 15cm
X-Large: 60cm x 30cm | 10cm x 20 cm
10 cm x 30 cm
10 cm x 40 cm
15 cm x 15 cm
15 cm x 20 cm
15 cm x 30 cm
20 cm x 20 cm
25 cm x 25 cm | |
| Sterility | Ethylene oxide sterilized | Ethylene oxide sterilized | Ethylene oxide sterilized | |
| Exudate handling | Canister | Canister | Dressing | |
| Therapeutic
pressure | -40mmHg to -200mmHg
with Invia Liberty
-40mmHg to -175mmHg
with Invia Motion
-40mmHg to -200mmHg
with Invia Ease | -40mmHg to 200mmHg with Invia
Liberty
-40mmHg to 175mmHg with Invia
Motion
-40mmHg to 200mmHg with Invia
Ease | -80mmHg (nominal) | |
| Mode
of
operation | Constant | Constant
Intermittent | Constant | |
| Maximum
Dressing change
interval of the
dressing | Up to 7 days (if without
wound filler) | Up to 3 days | Up to 7 days (if without
wound filler) | |
| Maximum
Dressing change
interval when
using dressing
with foam | Up to 3 days | Up to 3 days | Up to 3 days | |
| Characteristics | Subject Device
Invia
Integrated
Dressing | Predicate Device
Invia Foam Dressing Kit
with FitPad (K172145) | Reference Device
PICO 7 (K202157) | |
| Wound filler | Invia Black Foam NPWT | Invia Foam Dressing Kit
with FitPad | Smith&Nephew Inc. Foam
or gauze wound fillers. | |
| Wound filler
Sterilization
method | Ethylene oxide sterilized | Ethylene oxide sterilized | Ethylene oxide sterilized | |
| Compatibility
with other wound
filler included in
the kits | Invia Foam Dressing Kit with FitPad (K172145) Invia White Foam (K180415) Invia Gauze Dressing Kit (K172145) | Black foam included in the Invia Foam Dressing Kit with FitPad (K172145) White foam include in Invia White Foam (K180415) Gauze included in Invia Gauze Dressing Kit (K172145) | Smith&Nephew Inc. Foam dressing filler (REF 60801021) Gauze dressing filler (66801020) | |
7
8
9
Summary of Non-Clinical Tests
The Invia® Integrated Dressing and Invia® Black Foam NPWT wound filler comply with voluntary standards for sterilization, biocompatibility and usability. The following performance data are provided in support of the substantial equivalence determination:
- . Risk analysis in accordance with ISO 14971:2019. Medical Devices - Application of Risk Management to Medical Devices.
- . Sterilization information in accordance with the FDA's Guidance document entitled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." (January 2016).
- . A biocompatibility evaluation was completed according to the FDA's Guidance document entitled "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" (Sept. 2020). The Invia Integrated Dressing and the Invia Black Foam NPWT were categorized as having prolonged contact with breached or compromised surfaces. The following biological endpoints were evaluated based on this categorization: Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Systemic toxicity (acute), Pyrogenicity, and Subchronic toxicity (subacute toxicity).
- A summative human factors study was performed for the Invia Integrated Dressing ● following the FDA Guidance document "Applying Human Factors and Usability Engineering to Medical Devices" dated February 03, 2016. Overall, the objectives of the study were met, which demonstrated that the product can be used safely and effectively by lay users without patterns of preventable use errors that may cause harm to the user.
- Bench testing was conducted to check that specifications were met and to demonstrate . performance equivalence to the predicate Invia® Foam Dressing Kit with FitPad. Verification and validation tests have been executed for the Invia® Integrated Dressing in combination with all Medela Invia NPWT Systems: Invia® Liberty, Invia® Motion and Invia Ease. Additionally, the subject device has been tested in combination with the following wound fillers: Invia® Black Foam NPWT, the black foam wound fillers included in the Invia® Foam Dressing Kit with FitPad, the Invia® White Foam, and the gauze wound filler included in the Invia® Gauze Dressing Kit.
- Animal Testing was conducted to demonstrate that the subject device can be left in place ● over the wound for up to 7 days, before proceeding with the dressing change, without any adverse local tissue reactions, macroscopically or histopathologically. This study was conducted in compliance with the OECD Principles of Good Laboratory Practice (as revised in 1997), which are in conformity with other international GLP regulations (21 CFR Part 58).
Summary of Clinical Tests
Clinical testing was not required to support substantial equivalence.
10
Conclusions
The differences between the Invia® Integrated Dressing and its predicate device, Invia Foam Dressing Kits With FitPad, do not introduce a new intended use and do not raise different questions of safety and effectiveness. Verification and validation testing demonstrated that no adverse effects have been introduced by these differences and that the devices perform as intended.
From the results of nonclinical testing, Medela AG concludes that the Invia® Integrated Dressing is substantially equivalent to the legally marketed predicate device.