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.™ 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.

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.

AI/ML Overview

After reviewing the provided document, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested.

The document is an FDA 510(k) clearance letter and its associated summary for the PROMOGRAN PRISMA Matrix wound dressing. This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and performance data for an AI/ML-driven medical device.

Here's why the requested information cannot be extracted:

Device Type: PROMOGRAN PRISMA Matrix is a wound dressing, a physical medical device, not an AI/ML-driven diagnostic or therapeutic system.
Study Focus: The "Performance Data" section (page 11) explicitly states:
- "Summary of non-clinical tests conducted for determination of substantial equivalence": This refers to biocompatibility and bench studies for the physical dressing and its compatibility with Negative Pressure Wound Therapy, not an algorithm's performance.
- "Summary of clinical tests conducted for determination of substantial equivalence": This states "No clinical tests were necessary to demonstrate acceptable use of the Promogran Prisma™ with ActiV.A.C.™ Negative Pressure Wound Therapy." It mentions a "human factors engineering assessment" with 30 subject nurses and doctors to ensure changes to labeling for combined use are safe and effective. This is not a study proving an AI/ML device's diagnostic performance.
Absence of AI/ML Specifics: There is no mention of algorithms, machine learning models, image analysis, diagnostic performance metrics (e.g., sensitivity, specificity, AUC), ground truth establishment by experts, test sets, training sets, or MRMC studies, all of which are pertinent to AI/ML device evaluations.

Therefore, the requested tables and details pertaining to AI/ML device acceptance criteria and performance studies are not present in this document. The document describes a traditional medical device's clearance process based on substantial equivalence.

Summary

{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)

· 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.

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}------------------------------------------------

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."

{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
Establishmentregistrationnumber	3017375200
Name of contact person	Margaret Marsh, Regulatory Affairs Advanced Specialiste-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)]

{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.

· Diabetic ulcers
Venous ulcers
Pressure ulcers
· Partial-thickness burns
Traumatic wounds healing by secondary intention
Dehisced surgical wounds.

{8}------------------------------------------------

	Subject Device	Predicate Device
Comparator	(Promogran Prisma™ Used without and with the ActiV.A.C.™Negative Pressure Wound Therapy System)	(INTEGRA Meshed BilayerWound Matrix)
Indications forUse	Promogran Prisma™ when usedwithout the ActiV.A.C.™ NegativePressure Wound Therapy is intendedfor the management of exudingwounds.Under the supervision of a health careprofessional, Promogran Prisma™ maybe used for the management of:Diabetic ulcersVenous ulcersPressure ulcersUlcers caused by mixed vascularetiologiesFull-thickness & partial thicknesswoundsDonor sites and other bleedingsurface woundsAbrasionsTraumatic wounds healing bysecondary intentionDehisced surgical wounds.Compression therapy may only be used with Promogran Prisma™ under professional healthcare supervision. Compression therapy may not be used whenPromogran Prisma™ is used with ActiV.A.C.™ Negative Pressure WoundTherapy.	Promogran Prisma™ when used withthe ActiV.A.C.™ Negative PressureWound Therapy System is intended forthe management of exuding wounds.Under the supervision of a health careprofessional, Promogran Prisma™ withActiV.A.C.™ Negative PressureWound Therapy may be used only forthe management of:Venous ulcersPressure ulcersDiabetic ulcersPartial-thickness burnsTraumatic wounds healing bysecondary intentionDehisced surgical wounds.	INTEGRA™ Meshed BilayerWound Matrix is indicated for themanagement of wounds including:Partial and full-thicknesswounds,Pressure ulcers,Venous ulcers,Diabetic ulcers,Chronic vascular ulcers,Surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-laser surgery,podiatric, wounddehiscence),Trauma wounds (abrasions,lacerations, second degreeburns, and skin tears) andDraining wounds.May be used in conjunction withnegative pressure wound therapy.The device is intended for one-timeuse.
Care Setting	Care setting: Acute and extended care settings; home care setting where theapplication of the dressing and therapy is by the clinician only and not by thepatient.		Care setting not indicated inlabeling
Comparator	Subject Device(Promogran Prisma™ Used without and with the ActiV.A.C.™Negative Pressure Wound Therapy System)		Predicate Device(INTEGRA Meshed BilayerWound Matrix)
Duration ofTherapy	Promogran Prisma™ when usedwithout ActiV.A.C.™ NegativePressure Wound Therapy can bereapplied to the wound daily or perphysician recommendation.	The length of combined treatment forPromogran Prisma™ withActiV.A.C.™ Therapy should notexceed 30 days. During this therapyinterval, the V.A.C.® Granufoam™Dressings must be changed at aminimum of every 72 hours. Dressingchange intervals should be based on acontinuing evaluation of the woundcondition and the patients' clinicalpresentation, rather than a fixedschedule."	Duration for use of the matrixnot indicated in labeling."Change the secondary dressingas needed. Frequency ofsecondary dressing change willbe dependent upon volume ofexudate produced, type ofdressing used and the clinician'sneed to inspect the wound bedfor signs of infection orhealing."
Wound Types	Promogran Prisma™ when usedwithout ActiV.A.C.™ NegativePressure Wound Therapy is intendedfor the management of:Diabetic ulcersVenous ulcersPressure ulcersUlcers caused by mixed vascularetiologiesFull-thickness & partial thicknesswoundsDonor sites and other bleedingsurface woundsAbrasionsTraumatic wounds healing bysecondary intentionDehisced surgical wounds.	Promogran Prisma™ when used withthe ActiV.A.C.™ Negative PressureWound Therapy System is intended forthe management ofVenous ulcersPressure ulcersDiabetic ulcersPartial-thickness burnsTraumatic wounds healing bysecondary intentionDehisced surgical wounds.	Partial and full-thicknesswounds,Pressure ulcers,Venous ulcers,Diabetic ulcers,Chronic vascular ulcers,Surgical wounds (donorsites/grafts, post-Moh'ssurgery, post-laser surgery,podiatric, wounddehiscence),Trauma wounds (abrasions,lacerations, second degreeburns, and skin tears) andDraining wounds.
	Subject Device(Promogran Prisma™ Used without and with the ActiV.A.C.™Negative Pressure Wound Therapy System)	Predicate Device(INTEGRA Meshed BilayerWound Matrix)
Comparator
Wound Sizes	There are no labeled limitations pertaining to wound size for applying the dressing. The surface area of the selecteddressing would necessarily limit the size of the wound to be managed.	The surface area of the selected
WoundContactDressingMaterial	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 WoundDressing is comprised of:a porous matrix of cross-linkedbovine tendon collagen andglycosaminoglycan 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 thewound and then covered with a userselected semi-occlusive dressing or anon-occlusive secondary dressing andfixed to the skin with a non-irritatingtape.	When used with ActiV.A.C.™Negative Pressure Wound Therapy,Promogran Prisma™ is placed into thewound over which is positioned theV.A.C.® Granufoam™ orV.A.C.® Simplace™ Dressing. TheV.A.C.® Drape is used to cover thedressed wound and is connected via atubing set to the canister placed in theActiV.A.C.™ Therapy Unit.	The INTEGRA™ Bilayer MatrixWound Dressing is placed into thewound and covered with asecondary dressing (selected by theuser) to maintain dressingadherence and protect the woundarea.

{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.

Regulation Number and Section

N/A