(26 days)
Convertors® Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of transfer of microorganisms body fluids and particulate The gown is a single use material. disposable device intended for repackaging and sterilization before use.
The single use product is a disposable non-sterile gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial moist Heat Sterilization Ethylene Oxide following and the Validation and Routine Control under ANSI/AMMI/ISO 11134 7 11135. For more information about sterilization of this product, contact Cardinal health, Inc.
SMS polyolefin, the standard, fabric and poly-reinforced gowns are comprised of a single layer of SMS polyolefin fabric. The fabricreinforced gowns have an additional layer of SMS polyolefin fabric in the sleeve and body areas; the polyreinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.
The Breathable Surgical Gown with Breathable sleeves consists of an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt non-woven (SMS) with polyolefin-based film reinforcement.
The Breathable gown is comprised of a single layer of spunlace non-woven fabric (a blend of wood pulp and polyester) through the gown. An additional layer of breathable film adhesive laminated to the non-woven fabric in two configurations 1) through the entire gown and 2) in the front and sleeves.
The O. R. Surgical gowns are comprised of a wood pulp/polyester spunlaced fabric.
The provided text describes the Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, and O.R. Surgical Gowns. This document is a 510(k) summary for these surgical gowns, and it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for the device itself.
Therefore, much of the requested information regarding detailed performance studies, sample sizes for test sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance, as typically found for AI/ML medical devices, is not present in this document because it pertains to traditional medical device clearance based on substantial equivalence.
However, I can extract the available information, particularly regarding the acceptance criteria as defined by the "performance attributes" being the same as the predicate devices, and the general testing conducted.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of explicit numerical acceptance criteria and corresponding device performance values. Instead, the primary "acceptance criterion" for this 510(k) clearance is substantial equivalence to existing predicate devices. This means that the new devices are considered safe and effective if their performance attributes are "the same" as the legally marketed predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use: To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Single use, disposable, intended for repackaging and sterilization before use. | The Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, Breathable Surgical Gowns, and O. R. Surgical Gowns have the same intended use as the current SMS Polyolefin Gowns, Breathable Surgical Gowns, Breathable Surgical Gowns, and O. R. Surgical Gowns (predicate devices). |
| Performance Attributes: Expected to perform equivalently to predicate devices in protection against microorganisms, body fluids, and particulate material. | The performance attributes are the same as the predicate devices. Testing was conducted: - Biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices": Cytotoxicity, sensitization, and primary skin irritation were performed and found acceptable. - Industry recognized test methods: Materials were tested and found acceptable for the intended use. (Specific tests/results are not detailed). |
| Sterilization: Ability to withstand specified sterilization methods (Industrial Moist Heat Sterilization and Ethylene Oxide). | The single-use product is designed to be repackaged and sterilized prior to use. It may be sterilized using Industrial Moist Heat Sterilization (under ANSI/AAMI/ISO 11134) and Ethylene Oxide (under ANSI/AAMI/ISO 11135). However, the SMS polyolefin reinforced gown cannot undergo steam sterilization as it may damage the impervious reinforcement; Ethylene Oxide is the only method for this specific gown. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the performance testing. The document states "All materials used in the fabrication of this Convertors® SMS Polyolefin Gowns... were evaluated through biological qualification safety tests" and "These materials also were tested in accordance with industry recognized test methods." The exact number of gowns or material samples tested is not provided.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be primarily lab-based (biological and material performance tests). The country of origin of the data is not specified beyond being generated by Cardinal Health Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided. The "ground truth" for this type of device clearance is generally established through adherence to recognized consensus standards for material properties and biological safety (e.g., ISO 10993) and comparison to predicate devices, rather than through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typical in diagnostic studies where multiple readers interpret images. This document describes material and biocompatibility testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. MRMC studies are relevant for diagnostic devices that involve human interpretation assisted by AI. This document is for surgical gowns.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Consensus Standards: Adherence to established standards such as ISO 10993 Part-1 for biological evaluation of medical devices.
- Industry Recognized Test Methods: Performance against established material and barrier property tests.
- Predicate Device Equivalence: The performance of the new gowns is considered "acceptable" because their intended use and performance attributes are "the same" as legally marketed predicate devices.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/not provided. There is no "training set" as this is not an AI/ML device.
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K06/308
Image /page/0/Picture/1 description: The image contains the logo for Cardinal Health. The logo consists of the text "CardinalHealth" in a simple, sans-serif font. Above the text, there is a stylized graphic of three curved lines that converge at a point, resembling a bird in flight or a stylized checkmark.
JUN - 5 2006
Cardinal Health Inc. 1500 Waukegan Road McGaw Park, Illinois 60085 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Convertors® SMS Polyolefin Gowns, Breathable, Surgical Gowns, Breathable Surgical Gowns and O. R. Surgical Gowns
| Manufacturer: | Cardinal Health Inc.One Butterfield TrailEl Paso, Texas 79906 |
|---|---|
| Regulatory Affairs Contact: | Lavenia Ford1500 Waukegan Road MPWMMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3323 |
Telephone:
Date Summary Prepared:
Common Name:
Classification:
Predicate Device:
Description:
Class II per 21CFR § 878.4040
April 24, 2006
Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns, Breathable Surgical Gowns and O. R Surgical Gowns
Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns with
Breathable sleeves, Breathable Surgical Gowns and Optima Surgical Gowns
SMS polyolefin, the standard, fabric and poly-reinforced gowns are
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comprised of a single layer of SMS polyolefin fabric. The fabricreinforced gowns have an additional layer of SMS polyolefin fabric in the sleeve and body areas; the polyreinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.
The Breathable Surgical Gown with Breathable sleeves consists of an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film throughout the entire gown. The Breathable Sleeve Surgical Gown consists of sleeves containing an outer and inner layer of spunmelt polyolefin non-woven fabric with a middle layer of breathable monolithic film with a gown body comprised of spunmelt non-woven (SMS) with polyolefin-based film reinforcement.
The Breathable gown is comprised of a single layer of spunlace non-woven fabric (a blend of wood pulp and polyester) through the gown. An additional layer of breathable film adhesive laminated to the non-woven fabric in two configurations 1) through the entire gown and 2) in the front and sleeves.
The O. R. Surgical gowns are comprised of a wood pulp/polyester spunlaced fabric.
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Image /page/2/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that converge at a point, resembling a bird in flight or a stylized medical symbol. The text "CardinalHealth" is written in a simple, sans-serif font, with the two words joined together.
Cardinal Health Inc. 1500 Waukegan Road McGaw Park, Illinois 60085 847.473.1500 FAX: 847.785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Convertors® SMS Polyolefin Gowns, Breathable, Surgical Gowns, Breathable Surgical Gowns and O. R. Surgical Gowns
- Intended Use: Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of transfer of microorganisms body fluids and particulate The gown is a single use material. disposable device intended for repackaging and sterilization before use.
The single use product is a disposable non-sterile gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial moist Heat Sterilization Ethylene Oxide following and the Validation and Routine Control under ANSI/AMMI/ISO 11134 7 11135. For more information about sterilization of this product, contact Cardinal health, Inc.
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| SubstantialEquivalence: | The Convertors® non-sterile gowns aresubstantially equivalent to the Convertors®SMS Polyolefin Gowns, Breathable SurgicalGowns, Breathable Surgical Gowns and O. R.Surgical Gowns have the same intended useas the current SMS Polyolefin Gowns,Breathable Surgical Gowns, BreathableSurgical Gowns and O. R. Surgical Gowns. |
|---|---|
| - the intended use is the same | |
| - the performance attributes are the same | |
| Summary of Testing | All materials used in the fabrication of thisConvertors® SMS Polyolefin Gowns,Breathable Surgical Gowns, BreathableSurgical Gowns and O. R. Surgical Gownshave the same intended use that includes thesame indication for use as the current SMSPolyolefin Gowns, Breathable Surgical Gowns,Breathable Surgical Gowns and O. R. SurgicalGowns were evaluated through biologicalqualification safety tests as outlined in ISO10993 Part-1 "Biological Evaluation of MedicalDevices". The biocompatibility tests performedwere cytotoxicity, sensitization, and primaryskin irritation. These materials also weretested in accordance with industry recognizedtest methods and were found to be acceptablefor the intended use. |
.
:
:
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted in black, and the text is also in black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2006
Ms. Lavenia Ford Manager, Regulatory Affairs Cardinal Health 200 Incorporated 1500 Waukegan Road McGaw Park, Illinois 60685
Re: K061308
Trade/Device Name: Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns Breathable Surgical Gowns and O.R. Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 24, 2006 Received: May 10, 2006
Dear Ms. Ford:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Ford
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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REVISED
Image /page/6/Picture/1 description: The image shows the logo for Cardinal Health. The logo is in black and features the company name in a simple, sans-serif font. The word "Cardinal" is connected to the word "Health".
Cardinal Health Inc. 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847,473,1500 F6X- 847 785 2461
510(k) Number (if known): _ _ _ _ _ 06 /30 / 30 8
. Device Name:
Indications For Use:
Convertors® SMS Polyolefin Gowns, Breathable Surgical Gowns Breathable Surgical Gowns and O. R. Surgical Gowns
Convertors@Surgical gowns are made from natural and synthetic materials that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The gown is a single use disposable device intended for repackaging and sterilization before use.
This single use product is a disposable non-sterile surgical gown designed to be repackaged and sterilized prior to use. This product may be sterilized using Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization and Ethylene Oxide the Validation and Routine Control under following ANSVAMMI/ISO 11134 & 11135. For more information about sterilization of this product, contact Cardinal Health, Inc.
The exception for sterilization is that the SMS polyolefin reinforced gown, cannot under go steam sterilization. sterilization may damage the impervious Steam reinforcement on the gown. Ethylene Oxide is the only method of sterilization for this gown.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
on of Anasthesiology, General Hospital. Jon Control, Dental Devices
40 K061308
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.