(401 days)
No
The device description and performance studies focus on the material composition and physical properties of the wound dressing, with no mention of AI or ML capabilities.
Yes
The device is described as a primary dressing intended for the management of various types of exuding wounds, including diabetic, venous, and pressure ulcers, which are medical conditions that require treatment. It is used under the supervision of a healthcare professional.
No
The device description and intended use indicate that Promogran Prisma™ is a wound dressing designed for the management and healing of exuding wounds. It does not perform any diagnostic function.
No
The device description clearly states it is comprised of physical materials (oxidized regenerated cellulose, collagen, and silver ORC) and is a primary dressing. It is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Promogran Prisma™ is for the management of exuding wounds. This involves applying a dressing to a wound to aid in healing.
- Device Description: The device is described as a primary dressing made of specific materials (ORC, collagen, silver ORC). It's a physical product applied to the wound surface.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, tissue) to provide diagnostic information about a disease or condition. Its function is therapeutic, not diagnostic.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. Promogran Prisma™ is used in vivo (on the body) for wound management.
N/A
Intended Use / Indications for Use
Promogran Prisma™, when used without ActiV.A.C.™ Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ may be used for the management of:
- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- Ulcers caused by mixed vascular etiologies
- Full-thickness & partial thickness wounds
- Donor sites and other bleeding surface wounds
- Abrasions
- Traumatic wounds healing by secondary intention
- Dehisced surgical wounds.
Promogran Prisma™ when used with ActiV.A.C.TM Negative Pressure Wound Therapy is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ with ActiV.A.C.TM Negative Pressure Wound Therapy may be used only for the management of:
- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- Partial-thickness burns
- Traumatic wounds healing by secondary intention
- Dehisced surgical wounds.
Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ is used with ActiV.A.C.™ Negative Pressure Wound Therapy.
Product codes (comma separated list FDA assigned to the subject device)
FRO, OM
Device Description
3MTM Promogran Prisma™ is comprised of a sterile, freeze-dried composite of 44% oxidized regenerated cellulose (ORC), 55% collagen and 1 % silver ORC. Silver ORC contains 25% w/w ionically bound silver.
It is a primary dressing that can be cut with scissors to fit the wound and used in combination with either a semiocclusive or non-occlusive secondary dressing. The dressing is hexagonal in shape, provided in two sizes (28 cm² and 123 cm²) that are packaged in a hexagonal thermoformed tray and sterilized by gamma irradiation.
As described in the product labeling, when used with the ActiV.A.C.TM Negative Pressure Wound Therapy System, seven slits are cut into the 3M™ Promogran Prisma™ by the health care provider before applying the dressing and the components of the ActiV.A.C.™ Negative Pressure Wound Therapy System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the supervision of a health care professional.
Care setting: Acute and extended care settings; home care setting where the application of the dressing and therapy is by the clinician only and not by the patient.
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)
Summary of Non-clinical tests:
Promogran Prisma " was previously tested for biocompatibility under 510(k) K033523; tests included cytotoxicity, sensitization, irritation, material mediated pyrogenicity, systemic toxicity, and implantation end points. The design change to require the healthcare professional to slit the dressing before use with ActiV.A.C.™ Negative Pressure Wound Therapy does not require new biocompatibility testing.
Delivery of ActiV.A.C.™ Negative Pressure Wound Therapy to the wound under the Promogram Prisma" was assessed in bench studies using simulated wound exudate, maximum air leak rate, and under worst case dressing configuration. The results document that the Promogran Prisma™ does not inhibit delivery of negative pressure within specification at the low and high end of the recommended therapy settings.
Summary of Clinical tests:
No clinical tests were necessary to demonstrate acceptable use of the Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy. However, human factors engineering assessment with 30 subject nurses and doctors documented that the changes to the labeling, to describe use with ActiV.A.C.The Negative Pressure Wound Therapy, are safe and effective for their intended use.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is in blue and consists of the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font. To the left of the FDA logo is the Department of Health & Human Services logo, which is a stylized human figure.
May 10, 2022
3M Health Care Business Group Margaret Marsh Regulatory Affairs Advanced Specialist 3M Centre, Cain Road Berkshire, Bracknell Forest, RG12 8HT, United Kingdom
Re: K210135
Trade/Device Name: PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing Regulatory Class: Unclassified Product Code: FRO
Dear Margaret Marsh:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 24, 2022. Specifically, FDA is updating this SE Letter as an administrative correction to the Indications for Use (IFU).
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, julie.morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, PhD 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
1
Image /page/1/Picture/0 description: The image contains two logos. On the left is the Department of Health and Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 24, 2022
3M Health Care Business Group Margaret Marsh Regulatory Affairs Advanced Specialist 3M Centre, Cain Road Berkshire, Bracknell Forest, RG12 8HT, United Kingdom
Re: K210135
Trade/Device Name: PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 18, 2021 Received: January 19, 2021
Dear Margaret Marsh:
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 mav, 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
2
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 (OS) 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie A. Morabito -S
Julie 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
3
Indications for Use
510(k) Number (if known) K210135
Device Name 3MTM Promogran PrismaTM
Indications for Use (Describe)
Promogran Prisma™, when used without ActiV.A.C.™ Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ may be used for the management of:
- · Diabetic ulcers
- Venous ulcers
- · Pressure ulcers
- · Ulcers caused by mixed vascular etiologies
- · Full-thickness & partial thickness wounds
- · Donor sites and other bleeding surface wounds
- · Abrasions
- · Traumatic wounds healing by secondary intention
- · Dehisced surgical wounds.
Promogran Prisma™ when used with ActiV.A.C.TM Negative Pressure Wound Therapy is intended
for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ with ActiV.A.C.TM Negative Pressure Wound Therapy may be used only for the management of:
- · Diabetic ulcers
- Venous ulcers
- · Pressure ulcers
- · Partial-thickness burns
- · Traumatic wounds healing by secondary intention
- · Dehisced surgical wounds.
Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ is used with ActiV.A.C.™ Negative Pressure Wound Therapy.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
510(k) SUMMARY - K210135 3MTM Promogran Prisma™
February 24, 2022 Date prepared
Submitter information [21 CFR 807.929(a)(1)]
| Name | Systagenix Wound Management Limited, now a part of 3M Health Care Business Group |
|---|---|
| Address | 3M Deutschland GmbH Health Care Business, Carl-Schurz-Str.1, 41453 Neuss, Germany |
| Establishment | |
| registration | |
| number | 3017375200 |
| Name of contact person | Margaret Marsh, Regulatory Affairs Advanced Specialist |
| e-mail: mlmarsh@mmm.com |
Name of the device [21 CFR 807.92(a)(2)]
| Trade or | 3M™ Promogran Prisma™, Small |
|---|---|
| proprietary | 3M™ Promogran Prisma™, Large |
| name |
Wound Dressing with a Drug Component that can be used with or without Negative Pressure Common or usual name Wound Therapy
6
| Classification name/code | Primary Product Code:
Wound Dressing with a Drug Component (Silver)/FRO Secondary Product Code:
When used with Negative Pressure Wound Therapy:
Component of a Powered Negative Pressure Wound Therapy System/OM |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification regulation | Wound Dressing with a Drug Component (Silver): Unclassified |
| Classification panel | General and Plastic Surgery |
Legally marketed device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)
Integra™ Meshed Bilayer Wound Matrix (Integra LifeSciences Corp.), cleared under 510(k) K081635 for use with Negative Pressure Wound Therapy.
Device description [21 CFR 807.92(a)(4)]
3MTM Promogran Prisma™ is comprised of a sterile, freeze-dried composite of 44% oxidized regenerated cellulose (ORC), 55% collagen and 1 % silver ORC. Silver ORC contains 25% w/w ionically bound silver.
It is a primary dressing that can be cut with scissors to fit the wound and used in combination with either a semiocclusive or non-occlusive secondary dressing. The dressing is hexagonal in shape, provided in two sizes (28 cm² and 123 cm²) that are packaged in a hexagonal thermoformed tray and sterilized by gamma irradiation.
As described in the product labeling, when used with the ActiV.A.C.TM Negative Pressure Wound Therapy System, seven slits are cut into the 3M™ Promogran Prisma™ by the health care provider before applying the dressing and the components of the ActiV.A.C.™ Negative Pressure Wound Therapy System.
7
Indications for Use [21 CFR 807.92(a)(5)]
Promogran Prisma™, when used without ActiV.A.C.TM Negative Pressure Wound Therapy, is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ may be used for the management of:
- Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- · Ulcers caused by mixed vascular etiologies
- Full-thickness & partial thickness wounds
- · Donor sites and other bleeding surface wounds
- Abrasions
- Traumatic wounds healing by secondary intention
- Dehisced surgical wounds.
Promogran Prisma™ when used with ActiV.A.C.TM Negative Pressure Wound Therapy is intended for the management of exuding wounds. Under the supervision of a health care professional, Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy may be used only for the management of:
- · Diabetic ulcers
- Venous ulcers
- Pressure ulcers
- · Partial-thickness burns
- Traumatic wounds healing by secondary intention
- Dehisced surgical wounds.
Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when Promogran Prisma™ is used with ActiV.A.C.TM Negative Pressure Wound Therapy.
8
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Comparator | (Promogran Prisma™ Used without and with the ActiV.A.C.™ | ||
| Negative Pressure Wound Therapy System) | (INTEGRA Meshed Bilayer | ||
| Wound Matrix) | |||
| Indications for | |||
| Use | Promogran Prisma™ when used | ||
| without the ActiV.A.C.™ Negative | |||
| Pressure Wound Therapy is intended | |||
| for the management of exuding | |||
| wounds. | |||
| Under the supervision of a health care | |||
| professional, Promogran Prisma™ may | |||
| be used for the management of: | |||
| Diabetic ulcers | |||
| Venous ulcers | |||
| Pressure ulcers | |||
| Ulcers caused by mixed vascular | |||
| etiologies | |||
| Full-thickness & partial thickness | |||
| wounds | |||
| Donor sites and other bleeding | |||
| surface wounds | |||
| Abrasions | |||
| Traumatic wounds healing by | |||
| secondary intention | |||
| Dehisced surgical wounds. | |||
| Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used when | |||
| Promogran Prisma™ is used with ActiV.A.C.™ Negative Pressure Wound | |||
| Therapy. | Promogran Prisma™ when used with | ||
| the ActiV.A.C.™ Negative Pressure | |||
| Wound Therapy System is intended for | |||
| the management of exuding wounds. | |||
| Under the supervision of a health care | |||
| professional, Promogran Prisma™ with | |||
| ActiV.A.C.™ Negative Pressure | |||
| Wound Therapy may be used only for | |||
| the management of: | |||
| Venous ulcers | |||
| Pressure ulcers | |||
| Diabetic ulcers | |||
| Partial-thickness burns | |||
| Traumatic wounds healing by | |||
| secondary intention | |||
| Dehisced surgical wounds. | INTEGRA™ Meshed Bilayer | ||
| Wound Matrix is indicated for the | |||
| management of wounds including: | |||
| Partial and full-thickness | |||
| wounds, | |||
| Pressure ulcers, | |||
| Venous ulcers, | |||
| Diabetic ulcers, | |||
| Chronic vascular ulcers, | |||
| Surgical wounds (donor | |||
| sites/grafts, post-Moh's | |||
| surgery, post-laser surgery, | |||
| podiatric, wound | |||
| dehiscence), | |||
| Trauma wounds (abrasions, | |||
| lacerations, second degree | |||
| burns, and skin tears) and | |||
| Draining wounds. | |||
| May be used in conjunction with | |||
| negative pressure wound therapy. | |||
| The device is intended for one-time | |||
| use. | |||
| Care Setting | Care setting: Acute and extended care settings; home care setting where the | ||
| application of the dressing and therapy is by the clinician only and not by the | |||
| patient. | Care setting not indicated in | ||
| labeling | |||
| Comparator | Subject Device | ||
| (Promogran Prisma™ Used without and with the ActiV.A.C.™ | |||
| Negative Pressure Wound Therapy System) | Predicate Device | ||
| (INTEGRA Meshed Bilayer | |||
| Wound Matrix) | |||
| Duration of | |||
| Therapy | Promogran Prisma™ when used | ||
| without ActiV.A.C.™ Negative | |||
| Pressure Wound Therapy can be | |||
| reapplied to the wound daily or per | |||
| physician recommendation. | The length of combined treatment for | ||
| Promogran Prisma™ with | |||
| ActiV.A.C.™ Therapy should not | |||
| exceed 30 days. During this therapy | |||
| interval, the V.A.C.® Granufoam™ | |||
| Dressings must be changed at a | |||
| minimum of every 72 hours. Dressing | |||
| change intervals should be based on a | |||
| continuing evaluation of the wound | |||
| condition and the patients' clinical | |||
| presentation, rather than a fixed | |||
| schedule." | Duration for use of the matrix | ||
| not indicated in labeling. | |||
| "Change the secondary dressing | |||
| as needed. Frequency of | |||
| secondary dressing change will | |||
| be dependent upon volume of | |||
| exudate produced, type of | |||
| dressing used and the clinician's | |||
| need to inspect the wound bed | |||
| for signs of infection or | |||
| healing." | |||
| Wound Types | Promogran Prisma™ when used | ||
| without ActiV.A.C.™ Negative | |||
| Pressure Wound Therapy is intended | |||
| for the management of: | |||
| Diabetic ulcers | |||
| Venous ulcers | |||
| Pressure ulcers | |||
| Ulcers caused by mixed vascular | |||
| etiologies | |||
| Full-thickness & partial thickness | |||
| wounds | |||
| Donor sites and other bleeding | |||
| surface wounds | |||
| Abrasions | |||
| Traumatic wounds healing by | |||
| secondary intention | |||
| Dehisced surgical wounds. | Promogran Prisma™ when used with | ||
| the ActiV.A.C.™ Negative Pressure | |||
| Wound Therapy System is intended for | |||
| the management of | |||
| Venous ulcers | |||
| Pressure ulcers | |||
| Diabetic ulcers | |||
| Partial-thickness burns | |||
| Traumatic wounds healing by | |||
| secondary intention | |||
| Dehisced surgical wounds. | Partial and full-thickness | ||
| wounds, | |||
| Pressure ulcers, | |||
| Venous ulcers, | |||
| Diabetic ulcers, | |||
| Chronic vascular ulcers, | |||
| Surgical wounds (donor | |||
| sites/grafts, post-Moh's | |||
| surgery, post-laser surgery, | |||
| podiatric, wound | |||
| dehiscence), | |||
| Trauma wounds (abrasions, | |||
| lacerations, second degree | |||
| burns, and skin tears) and | |||
| Draining wounds. | |||
| Subject Device | |||
| (Promogran Prisma™ Used without and with the ActiV.A.C.™ | |||
| Negative Pressure Wound Therapy System) | Predicate Device | ||
| (INTEGRA Meshed Bilayer | |||
| Wound Matrix) | |||
| Comparator | |||
| Wound Sizes | There are no labeled limitations pertaining to wound size for applying the dressing. The surface area of the selected | ||
| dressing would necessarily limit the size of the wound to be managed. | The surface area of the selected | ||
| Wound | |||
| Contact | |||
| Dressing | |||
| Material | Promogran Prisma™ is comprised of a sterile, freeze dried composite of: | ||
| 44% oxidized regenerated cellulose (ORC) 55% bovine dermal collagen 1% silver-ORC (Silver-ORC contains 25 % w/w ionically bound silver) | INTEGRA Bilayer Matrix Wound | ||
| Dressing is comprised of: | |||
| a porous matrix of cross-linked | |||
| bovine tendon collagen and | |||
| glycosaminoglycan and a semi-permeable polysiloxane | |||
| (silicone) layer | |||
| Dressing Size | The dressing is hexagonal in shape and is provided in two sizes: | ||
| The small dressing is 28 cm² The large dressing is 123 cm² | 2 x 2 inch (5 x 5 cm) 4 x 5 inch (10 x 12.5 cm) 4 x 10 inch (10 x 25 cm) 8 x 10 inch (20 x 25 cm) | ||
| Sterilization | Gamma Irradiation | Gamma Irradiation | |
| System Design | When used without ActiV.A.C.™ | ||
| Negative Pressure Wound Therapy, | |||
| Promogran Prisma™ is placed into the | |||
| wound and then covered with a user | |||
| selected semi-occlusive dressing or a | |||
| non-occlusive secondary dressing and | |||
| fixed to the skin with a non-irritating | |||
| tape. | When used with ActiV.A.C.™ | ||
| Negative Pressure Wound Therapy, | |||
| Promogran Prisma™ is placed into the | |||
| wound over which is positioned the | |||
| V.A.C.® Granufoam™ or | |||
| V.A.C.® Simplace™ Dressing. The | |||
| V.A.C.® Drape is used to cover the | |||
| dressed wound and is connected via a | |||
| tubing set to the canister placed in the | |||
| ActiV.A.C.™ Therapy Unit. | The INTEGRA™ Bilayer Matrix | ||
| Wound Dressing is placed into the | |||
| wound and covered with a | |||
| secondary dressing (selected by the | |||
| user) to maintain dressing | |||
| adherence and protect the wound | |||
| area. |
9
10
11
Performance Data [21 CFR 807.92(b)]
Summary of non-clinical tests conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]
Promogran Prisma "" was previously tested for biocompatibility under 510(k) K033523; tests included cytotoxicity, sensitization, irritation, material mediated pyrogenicity, systemic toxicity, and implantation end points. The design change to require the healthcare professional to slit the dressing before use with ActiV.A.C.™ Negative Pressure Wound Therapy does not require new biocompatibility testing.
Delivery of ActiV.A.C.™ Negative Pressure Wound Therapy to the wound under the Promogram Prisma"" was assessed in bench studies using simulated wound exudate, maximum air leak rate, and under worst case dressing configuration. The results document that the Promogran Prisma™ does not inhibit delivery of negative pressure within specification at the low and high end of the recommended therapy settings.
Summary of clinical tests conducted for determination of substantial equivalence (21 CFR 807.92(b)(2)(
No clinical tests were necessary to demonstrate acceptable use of the Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy. However, human factors engineering assessment with 30 subject nurses and doctors documented that the changes to the labeling, to describe use with ActiV.A.C.The Negative Pressure Wound Therapy, are safe and effective for their intended use.
Conclusions drawn [21 CFR 807.92(b)(3)]
The subject device is substantially equivalent to the predicate device with respect to indications for use and wound dressing characteristics. There are no new questions regarding safety or effectiveness for the combined use of Promogran Prisma™ with the ActiV.A.C.TM Negative Pressure Wound Therapy System.