(211 days)
The gown is intended to protect the wearer from blood and other body fluids encountered during surgery
This surgical gown is similar in design and composition to the Kimberly Clark gown identified in a pre-market notification #K781682. The Kappler Med-Guard surgical gown is constructed from a tri-layer composite material which is a 100% polypropylene. The specific arrangement is spunbonded polypropylene/meltblown polypropylene film/spunbonded polypropylene. The fabric is treated with an anti-static agent.
The provided text describes a 510(k) summary for the Kappler Med-Guard Surgical Gown, focusing on its substantial equivalence to a predicate device (Kimberly Clark gown #K781682). The submission primarily relies on non-clinical testing to demonstrate performance and clinical testing to address the safety of an anti-static treatment. There is no information provided about AI or machine learning algorithms, therefore the questions related to AI-specific studies are not applicable.
Here's the breakdown of the acceptance criteria and the studies performed, based on the provided text:
Acceptance Criteria and Device Performance for Kappler Med-Guard Surgical Gown
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance characteristics of the predicate device (Kimberly-Clark surgical gown). The Kappler Med-Guard surgical gown aims to meet or exceed these characteristics to demonstrate substantial equivalence.
| Characteristic | Acceptance Criteria (Predicate Device K-C) | Reported Device Performance (Med-Guard) | Met Acceptance Criteria? |
|---|---|---|---|
| Material Composition | 100% Polypropylene | 100% Polypropylene | Yes |
| Configuration | Tri-laminate | Tri-laminate | Yes |
| Barrier Layer | Meltblown | Meltblown | Yes |
| Composite Weight | 1.5 oz./yd² | 1.8 oz./yd² | Yes (Equal or better) |
| Hydrostatic Head | 20.7 inches | 44.0 cm (approx. 17.3 inches) | No (Lower performance) |
| Bacterial Filtration | 81.3% | 78% | No (Lower performance) |
| Moisture Vapor Transmission Rate | 1794 grs/sqm/24 hr | 1789 g/24 hr m² | Yes (Comparable) |
| Flammability | Class 1 | Class 1 | Yes |
| Sterilization | 100% ETO | 100% ETO | Yes |
| Anti-static treatment | Yes | Yes | Yes |
Note on "Met Acceptance Criteria?": While some Med-Guard performance values (Hydrostatic Head, Bacterial Filtration) are numerically lower than the predicate, the FDA ultimately made a "substantially equivalent" determination. This suggests that these differences were deemed acceptable and did not raise new questions of safety or effectiveness. For example, a lower Hydrostatic Head might indicate less resistance to water, and lower bacterial filtration might mean slightly less protection. However, a slight variation within a functional range might still be considered equivalent for the intended use. The text doesn't provide the specific thresholds for "acceptable" values, only the comparison to the predicate.
2. Sample Size Used for the Test Set and the Data Provenance
Non-clinical testing: The text does not specify the exact sample sizes (number of gowns or material samples) for each non-clinical test (e.g., Hydrostatic Pressure Resistance, Bacterial Filtration Efficiency). It only states that "the individual test data sheets identify the samples as 'Blue Hawk'".
Clinical testing: The text does not specify the sample size (number of subjects or samples) for the clinical tests (Acute Systemic Toxicity, Cytotoxicity, Delayed Contact Sensitization Study).
Data provenance: Not specified, but given the nature of the tests (material properties, biological safety), they would be conducted in a laboratory setting, likely in the US, and are inherently prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable in the context of device performance testing. The "ground truth" here is the empirically measured physical and biological properties of the material and the device, as determined by standardized test methods (e.g., ASTM, MIL, NFPA). These are objective measurements rather than subjective expert opinion.
For the clinical testing, North American Science Associates, Inc. (NAmSA) established the protocol and evaluated the results, concluding no concerns. This suggests experts at NAmSA were involved, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. This relates to objective measurements from standard tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not relevant for a surgical gown. The submission evaluates the physical, barrier, and comfort characteristics, and the safety of anti-static treatment, not diagnostic accuracy requiring human reader interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not relevant for a surgical gown. There is no algorithm or AI component in this device.
7. The Type of Ground Truth Used
- Non-clinical testing: Objective, empirically measured physical and biological properties of the gown material, determined by adherence to established test standards (e.g., ASTM D 751, SOP/ARO/007F.1/MIL-M-36954C, ASTM E 96, NFPA 702, ASTM D 5733).
- Clinical testing: Results from standardized biological assays (Acute Systemic Toxicity, Cytotoxicity, Delayed Contact Sensitization Study) to assess biocompatibility and safety related to the anti-static treatment.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" as this device does not involve machine learning or AI.
{0}------------------------------------------------
510(k) Summary
- Kappler USA, Inc. a (1) PO Box 218 Guntersville, AL 35976
Contact: Philip Mann (256) 205-4146
Prepared: August 18, 1999
- a (2) Device Name: Surgical Gown Proprietary Name: Med-Guard Surgical Gown Classification Name: Gown, Surgical
- This surgical gown is similar in design and composition to the Kimberly Clark gown identified in a (3) pre-market notification #K781682.
- The Kappler Med-Guard surgical gown is constructed from a tri-layer composite material which is a (4) 100% polypropylene. The specific arrangement is spunbonded polypropylene/meltblown polypropylene film/spunbonded polypropylene. The fabric is treated with an anti-static agent.
- The surgical gown is intended to protect the wearer from blood and other body fluids encountered a (5) during surgery.
- a (6) The following table provides a comparison of the technological characteristics of the Kappler Med-Guard surgical gown and the Kimberly-Clark surgical gown. Description of the test methods are provided in section b.1. The K-C results were obtained from their own published literature.
| CHARACTERISTIC | MED-GUARD | K-C |
|---|---|---|
| Material Composition | 100% Polypropylene | 100% Polypropylene |
| Configuration | Tri-laminate | Tri-Laminate |
| Barrier Layer | Meltblown | Meltblown |
| Composite Weight | 1.8 oz./yd2 | 1.5 oz./yd2 |
| Hydrostatic Head | 44.0 cm | 20.7 inches |
| Bacterial Filtration | 78% | 81.3% |
| Moisture Vapor Transmission Rate | 1789 g/24 hm2 | 1794 grs/sqm/24 hr |
| Flammability | Class 1 | Class 1' |
| Sterilization | 100% ETO | 100% ETO |
| Anti-static treatment | Yes | Yes |
{1}------------------------------------------------
- The non-clinical testing was performed to describe the physical, barrier and comfort b (1) characteristics of the gown fabric. The individual test data sheets identify the samples as "Blue Hawk", which was a research and development name for the fabric in the Med-Guard gown.
Hydrostatic Pressure Resistance (ASTM D 751 Procedure B) - Provides a measure of the gown material resistance to a column of water. The results are expressed in the highest column resisted before failure occurs. See Enclosure A.
Bacterial Filtration Efficiency (SOP/ARO/007F.1/MIL-M-36954C) - Provides a measure of material resistance to bacteria laden aerosol with a mean particle size of approximately 3.0 microns. Results are expressed as a percentage of filtration. The test was performed on sterile material. See Enclosure B.
Moisture Vapor Transmission Rate (ASTM E 96 Method B) - Provides a measure of the gown material to pass water vapor and results are expressed in weight per unit area per unit time. Indicates a level of comfort for the wearer through ability to allow body perspiration to escape. See Enclosure C.
Standard Classification for Flammability (NFPA 702) - Provides a measure of the rate of burning of the gown material when ignited. Med-Guard shows the Class I flammability, which is defined as "relatively slow burning". See Enclosure D.
Ball Bursting Strength (ASTM D 751, Sec. 18.2) - Provides a measure of the physical strength of the gown material. Testing was performed on both sterile and non-sterile material to ensure sterilization would not adversely impact seam strength. See Enclosure E.
Breaking Strength (ASTM D 751, Sec. 11, Procedure A-Grab) - Provides a measure of the physical strength of the gown material. Testing was performed on both sterile and non-sterile material to ensure sterilization would not adversely impact physical strength. See Enclosure E.
Tear Strength (ASTM D 5733, Trapezoid Procedure) - Provides a measure of the physical strength of the gown material. See Enclosure E.
Colorfastness Evaluation of Non-wovens - Study consisted of performing water and saline extracts on the product after exposure to a normal steam cycle. See Enclosure E.
The product is 100% ETO sterilized. See Enclosure F.
- b (2) The clinical testing was performed to ensure the addition of the anti-static treatments presented no concerns of safety and effectiveness. The clinical protocol was established by North American Science Associates, Inc. (NAmSA). The protocol provided for the following testing:
Acute Systemic Toxicity - Hemolysis Test provides data to support no evidence of toxic effects from exposure to the treatment. See Enclosure G.
Cytotoxicity - MEM Emultion is a measure of the cytotoxicity of extractable substances exposed to cellular monolayers. See Enclosure H.
Delayed Contact Sensitization Study - Provides data to show no evidence of irritation from exposure to the treatment. See Enclosure I.
Based on the results of the testing, NAmSA concluded that no concerns of safety or effectiveness resulted from the addition of the anti-static treatment.
{2}------------------------------------------------
- The results of the non-clinical and clinical tests show the Kappler Med-Guard gown to be safe and b (3) effective. The results also show the gown to be equivalent to the predicate device.
.
{3}------------------------------------------------
Image /page/3/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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2000
Mr. Philip C. Mann Technical and Customer Support Manager Kappler Protective Apparel & Fabrics P.O. Box 218 35976 Guntersville, Alabama
Re : K992445 Trade Name: Med-Guard Surgical Gown Requlatory Class: II Product Code: FYA Dated: January 24, 2000 January 28, 2000 Received:
Dear Mr. Mann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
{4}------------------------------------------------
Page 2 - Mr. Mann
the Federal Register. Please note: this response to your ene reactar notification submission does not affect any premarket notificacion baxilder sections 531 through 542 of obligation you might have the Electronic Product Radiation Che Act for devices ander one ederal laws or regulations.
This letter will allow you to begin marketing your device as first recei will as on the premarket notification. The FDA described in your sia ... puivalence of your device to a legally rinding of substancial equired in a classification for your markeed predicals and the your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in reguladiagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriance at (501) 333 tising of your device, please contact che promocion and liver at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Informacion on Jourision of Small Manufacturers Assistance obeathed from eno number (800) 638-2041 or (301) 443-6597 or at at its corr rrec namber (6:1/www.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Page _ of _
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K992445 |
| Device Name: | MED-GUARD, Surgical Gown |
Indications For Use:
The gown is intended to protect the pa wearer from blood and other body fivids encountered during surgery
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use √
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 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.