(64 days)
The Convertors® Surgical Gowns are devices 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 gowns are comprised of a single base layer of degradable spunlaced nonwoven fabric in gown configurations of unreinforced, fabric reinforced and poly-reinforced. The fabric reinforced gown contains an additional layer of spunlaced nonwoven fabric in the chest and sleeves area. The poly-reinforced gown contains an additional layer of polyolefin film in the chest and sleeves of the gown.
This document describes the "Convertors® Surgical Gowns" manufactured by Allegiance Healthcare Corporation. The information provided focuses on the regulatory submission (510(k)) for this medical device, which is a Class II device (per 21 CFR § 878.4040) used as surgical apparel.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of specific, quantifiable acceptance criteria with corresponding performance data. Instead, it describes general categories of testing and statements of acceptability, primarily focused on biocompatibility and general performance as compared to a predicate device.
| Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|
| Biocompatibility (Safety) | All materials used in the fabrication of Convertors® Surgical Gowns were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices." The biocompatibility tests performed were cytotoxicity, sensitization, and primary skin irritation. These materials were found to be acceptable for the intended use. |
| Performance Attributes (Protective Barrier) | The performance attributes are similar to the predicate device (Isolyser Industries Enviroguard Surgeons Gowns). This implies meeting the functional requirements for surgeons' gowns, such as protection against the transfer of microorganisms, body fluids, and particulate material. The term "similar" suggests that the Convertors® gowns perform comparably in these aspects to the predicate device. The document does not provide specific quantitative metrics (e.g., AAMI barrier levels, tear strength, linting) for either the acceptance criteria or reported performance. |
| Intended Use Equivalence | The intended use is the same as the predicate device (Isolyser Enviroguard gowns). This is explicitly stated as a point of substantial equivalence. The intended use is "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." |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for the test set(s) for either biocompatibility or performance testing. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a non-active medical device like a surgical gown, testing would typically be conducted under controlled laboratory conditions, and the data would likely be prospective from these dedicated tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. For device testing (e.g., biocompatibility, protective barrier), the "ground truth" is typically established by recognized standards and validated test methods, not necessarily by experts reviewing individual test results in a consensus manner. The "experts" in this context would be the technicians and scientists performing the tests and interpreting the results according to the test standards.
4. Adjudication Method for the Test Set:
This information is not provided and is generally not applicable to the type of device testing described (biocompatibility, material performance). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic device evaluations where subjective interpretation plays a significant role.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving interpretation by human readers (e.g., radiologists, pathologists) where AI might assist in improving performance. Surgical gowns do not fit this category.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No standalone (algorithm-only) performance was done. This is not applicable to a surgical gown, which is a physical barrier device, not an algorithm-driven diagnostic or treatment device.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is established by:
- Biocompatibility Standards: Specifically, ISO 10993 Part-1 "Biological Evaluation of Medical Devices" for cytotoxicity, sensitization, and primary skin irritation tests. The "ground truth" here is the pass/fail criteria defined within these international standards.
- Industry Recognized Test Methods: For other performance attributes (e.g., barrier effectiveness, strength), the document mentions testing in accordance with "industry recognized test methods." The "ground truth" would be the established performance thresholds or benchmarks within those specific test methods.
- Predicate Device Equivalence: A significant part of the "ground truth" for substantial equivalence is the demonstration that the new device's intended use and performance are "similar" to a legally marketed predicate device (Isolyser Industries Enviroguard Surgeons Gowns).
8. The Sample Size for the Training Set:
This information is not provided. This concept is primarily relevant for machine learning algorithms, which are not applicable to the testing of a surgical gown.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided, as the concept of a "training set" and establishing its ground truth is not applicable to the evaluation of a surgical gown.
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FEB 1 8 2000
Image /page/0/Picture/1 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a stylized graphic that resembles a cluster of dots arranged in a cross-like shape. The word "Allegiance" is the primary focus of the image, and the graphic serves as a visual element associated with the text.
K9942yy
Allegiance Healthcare Corporation 1500 •• Ξ – egan Road McGa.v. Park. Illinois 60085-6787 847.473.1500
FAX: 847.785.2461
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Gowns
| Manufacturer: | Allegiance Healthcare CorporationOne Butterfield TrailEl Paso, Texas 79906 |
|---|---|
| Regulatory Affairs Contact: | Sharon Robbins1500 Waukegan Road MPWMMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | September, 1999 |
| Common Name: | Convertors® Surgical Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Isolyser Industries Enviroguard Surgeons Gowns |
| Description: | The gowns are comprised of a single base layerof degradable spunlaced nonwoven fabric ingown configurations of unreinforced, fabricreinforced and poly-reinforced. The fabricreinforced gown contains an additional layer ofspunlaced nonwoven fabric in the chest andsleeves area. The poly-reinforced gown containsan additional layer of polyolefin film in the chestand sleeves of the gown. |
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Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a cross made up of small dots. The word is in black and the background is white.
Allegian se Healthcare Corporation 1500 Wajyegan Road McGaw -ark. Illinois 60085-6787 847.473 ・500
FAX: 8ニー 785.2461
SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Surgical Gowns
| Intended Use: | Surgical apparel are devices intended to be wornby operating room personnel during surgicalprocedures to protect both the surgical patientand the operating room personnel from thetransfer of microorganisms, body fluids andparticulate material. |
|---|---|
| Substantial Equivalence: | The Convertors® Surgical gowns aresubstantially equivalent to the IsolyserEnviroguard gowns in that: |
| - the intended use is the same- the performance attributes aresimilar | |
| Summary of testing: | All materials used in the fabrication of thisConvertors® Surgical gowns were evaluated throughbiological qualification safety tests as outlined in ISO10993 Part-1 "Biological Evaluation of MedicalDevices". The biocompatibility tests performed werecytotoxicity, sensitization, and primary skin irritation.These materials also were tested in accordance withindustry recognized test methods and were found tobe acceptable for the intended use. |
ー | 3,00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and its head turned to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
AUG 18 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sharon Robbins Regulatory Affairs Manager Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787
Re: K994244
Trade/Device Name: Convertors® Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical apparel Regulatory Class: II Product Code: FYA Dated: December 14, 1999 Received: December 16, 1999
Dear Ms. Robbins:
This letter corrects our substantially equivalent letter of February 18, 2000.
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 (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 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. Robbins
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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chiu S. Lin, Ph.D.
Chiu S. Lin, Ph. B Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Allegiance
Allegiance Healthcare Corporation 1500 Vi Engegan Road McGar. Fark. Illinois 60085-6787 847.2-3 -500 AX 5-- 785.2461
Page 1 of 1
510(k) Number (if known):
Unknown K99A244
Device Name:
Convertors® Surgical Gowns, Sterile
Indications For Use:
The Convertors® Surgical Gowns are devices 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The Counter Use Prescription Use ਾ (Per 21 CFR 801.109) (Division Sign-Off) Division of Dental, Infection C and General Hospital Device 510(k) Number
§ 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.