(175 days)
Not Found
No
The device description and performance studies focus on the physical properties and antimicrobial activity of the incise drape, with no mention of AI or ML.
Yes
The device provides antimicrobial activity to reduce the risk of microbial contamination in the surgical wound, which is a therapeutic function of preventing infection.
No
This device is an incise drape intended to provide a sterile barrier and antimicrobial activity during surgery, not to diagnose a condition.
No
The device is a physical incise drape with an adhesive containing an antimicrobial agent. It is a tangible product applied to the skin, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as an incise drape applied to the skin during surgery to provide a sterile barrier and antimicrobial activity. This is a direct application to the patient's body for a surgical procedure.
- Device Description: The device is a sterile adhesive film applied to the skin. It acts as a physical barrier and releases an antimicrobial agent.
- Lack of In Vitro Diagnostic Activities: The description does not mention any activities related to examining specimens (like blood, urine, tissue) in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions. The "in vitro time kill data" mentioned in the intended use refers to testing the antimicrobial activity of the CHG on the drape itself, not using the drape to test a patient sample.
- Performance Studies: The performance studies focus on the physical properties of the drape (barrier, tensile strength, flammability, MVTR), the release and activity of the antimicrobial agent, and its performance in an in vivo (in a living organism) animal model and clinical adhesion studies. These are not typical performance studies for an IVD.
In summary, the 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is a medical device used directly on the patient during surgery, not a device used to perform tests on patient samples outside the body.
N/A
Intended Use / Indications for Use
3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
Product codes
KKX
Device Description
The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is a sterile adhesive film that is applied pre-operatively to skin. The film adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The CHG contained in the adhesive provides antimicrobial activity to reduce the risk of microbial contamination in the surgical wound.
The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape consists of a transparent, conformable, breathable fluid barrier film laminated to a lightly-tinted, acrylic pressure-sensitive adhesive that contains 2% w/w Chlorhexidine Gluconate (CHG). The adhesive drape is delivered on a silicone-coated release liner that is discarded after application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench testing was performed to demonstrate substantial equivalence for this submission, as recommended by the FDA Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes and the additional recommendations from FDA Draft Guidance on Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents. Data submitted includes:
- Barrier performance per AAMI PB70:2012 using ASTM F1670 "Resistance to Synthetic Blood Penetration"
- Tensile and Elongation
- Flammability testing was performed per 16 CFR 1610
- Moisture Vapor Transmission Rate (MVTR)
- in vitro Antimicrobial Activity Spectrum and Minimum Effective Concentration (MEC) per ASTM E2315
- CHG Release Kinetics
In vivo animal efficacy data: In vivo animal testing was performed to demonstrate antimicrobial efficacy compared with a placebo incise drape. The study involved a wound contamination rates of test versus placebo drape in an in vivo porcine surgical model.
Results: At T0 Log10 CFU/sample, CHG drape was lower than placebo (observed difference 0.35 log10 , P=0.026). At T4 Log10 CFU/sample, CHG drape was lower than placebo (observed difference 0.68 log10 , P=0.001). The difference in change in log10 counts/sample from T0 to T4 was an observed difference of 0.34 log10 , P=0.14. Log10 CFU/cm² under drape was lower than placebo (observed difference 0.70 log10 , P=less than 0.001). Conclusion: Test article reduces microbial contamination of surgical wound compared to the placebo.
Clinical performance data: In house clinical panels were performed to demonstrate good adhesion to skin. Outside clinical adhesion studies were conducted to demonstrate safety and adhesion to various skin types. Safety data were collected in these studies to demonstrate substantial equivalence for this submission to the predicate, 3M™ Ioban™ 2 Antimicrobial Incise Drape.
- Adhesion to Skin - in house clinical panels: Adhesion comparison of 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M™ Ioban™ 2 Antimicrobial Incise Drape on skin prepped with DuraPrep Solution or a leading PVP-I prep solution during a wet challenge wear study. Result: No statistical difference in skin adhesion over either DuraPrep Solution or PVP-I prep solutions. Comparison: Same performance as predicate.
- Adhesion to skin - in house clinical panels: Adhesion comparison of 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape and 3M Ioban 2 Antimicrobial Incise Drape on skin during a dry challenge wear study. Result: Removal force of test article is higher than predicate, no difference in skin reactions. Comparison: Similar performance to predicate.
- Adhesion to skin - external clinical study: Evaluation of skin condition and removal force post-wear on subjects with very dry and potentially fragile skin types. Result: No adverse events associated with test article post-wear; removal force slightly higher for test article. Comparison: Similar performance to predicate.
Key Metrics
Not Found
Predicate Device(s)
3M™ Ioban™ 2 Antimicrobial Incise Drape (K801550)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
3M Infection Prevention
3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul. MN 55144 651 733 1110
JUL 2 5 2014
510(k) SUMMARY Sponsor Information:
SM
Applicant Name 3M Company 3M Health Care Infection Prevention Division 3M Center 2510 Conway Ave., Bldg 275-5W-06 St. Paul, MN 55144
Contact Person:
Phone Number: Fax Number: e-mail:
651-736-6117 651-737-5320 ktotushek@mmm.com
Kristin Totushek Regulatory Affairs
Date Prepared:
July 23, 2014
Device Name and Classification:
| Trade Name: | 3M™ Steri-Drape™ CHG
Antimicrobial Incise Drape |
|-----------------------|------------------------------------------------------|
| Common or Usual Name: | Antimicrobial Incise Drape |
| Classification Name: | Surgical Drape and Drape Accessories |
| Product Code: | KKX per 21CFR 878.4370 |
| Predicate Device: | 3M™ loban™ 2 Antimicrobial Incise Drape
(K801550) |
Description of Device:
The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is a sterile adhesive film that is applied pre-operatively to skin. The film adheres and conforms to body contours, providing a sterile surface on top of the skin prior to surgery. The surgeon incises through the adhesive film and skin, ensuring a sterile film barrier all the way to the edge of the incision. The CHG contained in the adhesive provides antimicrobial activity to reduce the risk of microbial contamination in the surgical wound.
1
3M Infection Prevention
3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110
The 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape consists of a transparent, conformable, breathable fluid barrier film laminated to a lightly-tinted, acrylic pressuresensitive adhesive that contains 2% w/w Chlorhexidine Gluconate (CHG). The adhesive drape is delivered on a silicone-coated release liner that is discarded after application.
In vitro testing demonstrates that 3MTM Steri-Drape™ CHG Antimicrobial Incise Drape has broad spectrum antimicrobial activity.
Indications for Use:
3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
| Catalog # | Color | Size | |
|---|---|---|---|
| 8840EZ | Light pink | 13 in x 13 in | 34 cm x 35 cm |
| 8848EZ | Light pink | 22 in x 23 in | 56 cm x 60 cm |
| 8850EZ | Light pink | 22 in x 17 in | 56 cm x 45 cm |
| 8851EZ | Light pink | 22 in x 33 in | 56 cm x 85 cm |
Substantial Equivalence:
3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is substantially equivalent to the predicate device, 3M™ Ioban™ 2 Antimicrobial Incise Drape cleared under K801550.
3MTM Steri-Drape™ CHG Antimicrobial Incise Drape is composed of the same or similar components and has the same or similar performance, intended use and indications for use as the predicate device.
Based on the similarities to the predicate device, the minor differences do not present any new safety or effectiveness issues and the device is substantially equivalent to the predicate.
Comparative Data for Determining Substantial Equivalence of New Device to Predicate Device:
| Characteristic | 3M™ Steri-Drape™
CHG Antimicrobial
Incise Drape | 3M™ Ioban™ 2
Antimicrobial Incise
Drape | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 3M™ Steri-Drape™
CHG Antimicrobial | 3M™ Ioban™ 2
Antimicrobial Incise | Same |
| Characteristic | 3MTM Steri-DrapeTM
CHG Antimicrobial
Incise Drape | 3MTM IobanTM 2
Antimicrobial Incise
Drape | Comparison |
| | Incise Drape is
indicated for use as
an incise drape with
continuous
antimicrobial activity.
It is intended for
external use only. | Drape is indicated for
use as an incise drape
with continuous
antimicrobial activity.
It is intended for
external use only. | |
| Design/Materials | Antimicrobial
impregnated adhesive
coated on breathable
film with silicone-
coated release liner. | Antimicrobial
impregnated adhesive
coated on breathable
film with silicone-
coated release liner. | Same |
| Antimicrobial | Chlorhexidine
Gluconate (CHG) | Iodine | Both are well
characterized, broad
spectrum,
antimicrobials. Safety
and efficacy testing
demonstrates
substantial
equivalence. |
| Sold Sterile | Yes | Yes | Same |
| Sterilization Method | Ethylene Oxide
sterilized, 106 SAL
per ISO 11135 | Gamma Sterilized,
106 SAL per ISO
11137 | Different sterilization
method but same
sterility assurance
level (SAL). Iodine
is not compatible
with Ethylene Oxide.
CHG is not
compatible with
gamma irradiation.
Both devices are
sterilized to 106 SAL
per respective ISO
standards. |
| Packaging | Film/Tyvek Pouch | Foil Pouch | Foil laminate is used
to protect Ioban from
EO exposure if
sterilized in a kit.
Film/Tyvek is used to
enable sterilization of
CHG drape with EO. |
| Sterility Assurance
Level | SAL 10-6 | SAL 10-6 | Same |
| Characteristic | 3M™ Steri-Drape™
CHG Antimicrobial
Incise Drape | 3M™ Ioban™ 2
Antimicrobial Incise
Drape | Comparison |
| Principals of
Operation | The 3M™ Steri-Drape™ CHG
Antimicrobial Incise
Drape is a sterile
adhesive film that is
applied pre-
operatively to skin.
The film adheres and
conforms to body
contours, providing a
sterile surface on top
of the skin prior to
surgery. The
surgeon incises
through the adhesive
film and skin,
ensuring a sterile film
barrier all the way to
the edge of the
incision. The CHG
contained in the
adhesive provides
additional
antimicrobial activity
to reduce the risk of
microbial
contamination of the
surgical wound. | The 3M™ Ioban™ 2
Antimicrobial Incise
Drape is a sterile
adhesive film that is
applied pre-
operatively to skin.
The film adheres and
conforms to body
contours, providing a
sterile surface on top
of the skin prior to
surgery. The
surgeon incises
through the adhesive
film and skin,
ensuring a sterile film
barrier all the way to
the edge of the
incision. The iodine
contained in the
adhesive provides
additional
antimicrobial activity
to reduce the risk of
microbial
contamination of the
surgical wound. | Same |
| Biocompatibility | Not cytotoxic, slight
irritant, not a
potential skin
sensitizer | Not cytotoxic, slight
irritant, not a
potential skin
sensitizer | Same |
2
3M Infection Prevention
3M Center
2510 Conway, Bldg 275-05-W-06
St. Paul. MN 55144
651 733 1110
3
3M Infection Prevention
3M Center 2510 Convay, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110
Bench Testing Performance Data:
Bench testing was performed to demonstrate substantial equivalence for this submission, as recommended by the FDA Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes and the additional recommendations from FDA Draft Guidance on Premarket Notification [510(k)]
4
3M Infection Prevention
3 M Center 2510 Conway. Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110
Submissions for Medical Devices that Include Antimicrobial Agents. Data submitted includes:
- Barrier performance per AAMI PB70:2012 using ASTM F1670 "Resistance to • Synthetic Blood Penetration"
- . Tensile and Elongation
- . Flammability testing was performed per 16 CFR 1610
- . Moisture Vapor Transmission Rate (MVTR)
- in vitro Antimicrobial Activity Spectrum and Minimum Effective Concentration . (MEC) per ASTM E2315
- . CHG Release Kinetics
5
3M Infection Prevention
3M Center
2510 Conway, Bldg 275-05-W-06
St. Paul, MN 55144 651 733 1110
| Characteristic | Test
Method
Description | Device
Component
Tested | Data Summary | | Comparison |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| | | | Test Article:
3MTM Steri-
Drape™ CHG
Anti-microbial
Incise Drape | Predicate:
3MTM
Ioban™ 2
Anti-
microbial
Incise Drape | |
| Tensile and
Elongation | Based on
PSTC-131,
ASTM
D882,
ASTM
D3759 | Finished
Drape Incise
Area,
sample cut
to size | Tensile > 1365
g/25mm and
Elongation
500% | Tensile >
1365
g/25mm and
Elongation
500% | Same |
| MVTR | Based on
ASTM E96
and Payne
Cup Method | Finished
Drape
sample, cut
to size | > 400 g/m²/24
hrs | > 400
g/m²/24 hrs | Same |
| Flammability | 16 CFR
1610 | Finished
Drape
Sample | Class I
(Normal) | Class I
(Normal) | Same |
| Barrier
Performance | AAMI
PB70:2012 | Finished
Drape
Sample, cut
to size | Level 4 | Level 4 | Same |
| Antimicrobial
performance | ASTM
E2315 | Finished
Drape
Sample, cut
to size | Broad
Spectrum, > 4
log reduction at
90 min | Broad
Spectrum, >.
4 log
reduction at
90 min | Same |
| Characteristic | Description
of Test
Method | Device Component
Tested | | Data
Summary | Conclusion |
| | | Test
Article | Placebo | | |
| Antimicrobial
efficacy study-
in vivo porcine
model | Wound
contamination
rates of test
versus
placebo drape
in an in vivo
porcine
surgical
model | Finished
Drape
sample,
cut to size. | Placebo
drape
sample, cut
to size. | T0 $Log_{10}$
CFU/sample
CHG drape
lower than
placebo
(observed
difference 0.35
$log_{10}$ , P=
0.026)
T4 $Log_{10}$
CFU/sample
CHG drape
lower than
placebo
(observed
difference 0.68
$log_{10}$ ,
P=0.001)
Difference in
change in $log_{10}$
counts/sample
T0 to T4,
observed
difference 0.34
$log_{10}$ , P=0.14
$Log_{10}$
CFU/cm²
under drape
lower than
placebo
(observed
difference 0.70
$log_{10}$ , P= | Test article
reduces
microbial
contamination
of surgical
wound
compared to
the placebo |
6
3M Infection Prevention
3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110
In vivo Animal Efficacy Data
In vivo animal testing was performed to demonstrate antimicrobial efficacy compared with a placebo incise drape.
7
3M 1nfection Prevention
3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110
Clinical Performance Data:
In house clinical panels were performed to demonstrate good adhesion to skin. Outside clinical adhesion studies were conducted to demonstrate safety and adhesion to various skin types.
Safety data were collected in these studies to demonstrate substantial equivalence for this submission to the predicate, 3M™ loban™ 2 Antimicrobial Incise Drape.
| Test | Device
Component
Tested | Testing Summary | Summary | Comparison |
|---------------------------------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Adhesion to
Skin - in house
clinical panels | Finished Drape
Samples, cut to
size | Adhesion
comparison of 3M™
Steri-Drape™ CHG
Antimicrobial Incise
Drape and 3M™
loban™ 2
Antimicrobial Incise
Drape on skin
prepped with
DuraPrep Solution or
a leading PVP-I prep
solution during a wet
challenge wear study | No statistical
difference in
skin
adhesion
over either
DuraPrep
Solution or
PVP-I prep
solutions | Same
performance as
predicate |
| Adhesion to
skin - in house
clinical panels | Finished Drape
Samples, cut to
size | Adhesion
comparison of 3M™
Steri-Drape™ CHG
Antimicrobial Incise
Drape and 3M loban
2 Antimicrobial
Incise Drape on skin
during a dry
challenge wear study | Removal
force of test
article is
higher than
predicate, no
difference in
skin
reactions | Similar
performance to
predicate |
| Adhesion to
skin - external
clinical study | Finished Drape
Samples, cut to
size | Evaluation of skin
condition and removal
force post- wear on
subjects with very dry
and potentially fragile
skin types | No adverse
events
associated
with test
article post-
wear;
removal
force slightly
higher for
test article | Similar
performance to
predicate |
8
3M Infection Prevention
3M Center 2510 Conway, Bldg 275-05-W-06 St. Paul, MN 55144 651 733 1110
Performance, Safety and Efficacy Conclusion:
Based on bench, animal and clinical studies, 3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is as safe, as effective and is demonstrated to be substantially equivalent to the predicate device, 3M™ lobanTM 2 Antinicrobial Incise Drape.
9
Image /page/9/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
3M Health Care Infection Prevention Division Ms. Kristin Totushek Regulatory Affairs Specialist 3M Center, 2510 Conway Ave. Bldg 275-5W-06 St. Paul, MN 55144
Re: K 140250
Trade/Device Name: 3MTM Steri-Drape ™ CHG Antimicrobial Incise Drape Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape Accessories Regulatory Class: Class II Product Code: KKX Dated: June 23, 2014 Received: June 24, 2014
Dear Ms. Totushek,
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. 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.
10
Page 2 - Ms. Totushek
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D. Clinical Deputy Director
Tejashri Purohit-Sheth, M.D. DAGRID/QDE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K140250
Device Name
3MTM Steri-Drape™ CHG Antimicrobial Incise Drape
Indications for Use (Describe)
3M™ Steri-Drape™ CHG Antimicrobial Incise Drape is indicated for use as an incise drape with continuous antimicrobial activity based on in vitro time kill data out to 90 minutes. It is intended for external use only.
| Catalog # Color | Size | ||
|---|---|---|---|
| 8840EZ | Light pink 13 in x 13 in 34 cm x 35 cm | ||
| 8848EZ ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- | Light pink 22 in x 23 in 56 cm x 60 cm | ||
| 8850EZ ----------------------------------------------------------------------------------------------------------------------------------------------------------------------- | Light pink 22 in x 17 in 56 cm x 45 cm | ||
| 8851EZ Light pink 22 in x 33 in 56 cm x 85 cm |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
[x] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Sreekanth Gutala -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, Sreekanth Guta ou=People, 0.9.2342.19200300.100.1.1=2000540490, cn=Sreekanth Gutala -S Date: 2014.07.24 11:04:33 -04'00' PSC Publuhing Services (301) 44)-6740 Es FORM FDA 3881 (1/14) Page 1 of 2
12
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