(116 days)
No
The device description and intended use clearly describe a simple disposable apron made of plastic, with no mention of any computational or analytical capabilities. The performance studies focus on material properties (viral penetration), not algorithmic performance.
No.
The device is described as a "Disposable Apron" intended to protect healthcare workers from the transfer of micro-organisms, blood, body fluids, and particulate material. It is a barrier device for protection, not for treatment or diagnosis of a disease or condition.
No
Explanation: The device, a Disposable Apron, is described as personal protective equipment intended to protect healthcare workers from the transfer of microorganisms, blood, and body fluids. It does not perform any diagnostic function such as detecting, examining, or monitoring health conditions or diseases.
No
The device description clearly states it is a physical apron made from Poly Vinyl, secured by slipping over the head and tying in the back. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect healthcare workers from the transfer of microorganisms, blood, body fluids, and particulate material. This is a protective barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical apron made of Poly Vinyl. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
The device is clearly intended as a personal protective equipment (PPE) item for healthcare workers.
N/A
Intended Use / Indications for Use
The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient.
The Disposable Apron is a disposable product intended for single use only.
Product codes
Not Found
Device Description
The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cover front of body and feet
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital environment
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
Summary of the Viral Penetration Test: ASTM Method F1671-95:
The ΦX174 bacteriophage challenge suspension will be maintained at a concentration of at least 1.0 X 10^8 PFU/ml (plaque forming units/mL). Test samples were propared by randomly cutting approximately 75mm x 75mm test swatches from the test material. Test samples were challenged with approximately 60 mL of a ΦX 174 bacteriophage suspension for 5 minutes at atmospheric pressure, 1 minute at 2.0 PSIG (13.8 kpa), and 54 minutes at atmospheric pressure or until liquid penetration was observed. At the conclusion of the test, the observed side of the test sample was rinsed with a sterile assay medium and then assayed for the presence of the ΦX 174 bacteriophings. The surface tension of the challenge suspension and the assay medium was adjusted to approximately 40-44 dynes/em using surf actant-type Tweents 80 at a final concentration of approximately 0.01% by volume. These samples were also tested for computibility of materials and test organisms. This testing was done by placing a 10 uL aliquot of a ΦX174 suspension containing a total of 900-1200 PFU near the center of the test sample after it had been clamped into the penetration test cell. After 60 minutes, the surface was rinsed with a sterile assay medium and then assayed for the presence of the ΦX174 bacteriophage.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Viral Penetration Test per ASTM Method F1671-95. The compatibility ratio for the Fluid Barner Boot was 1.3. The challenge level was manitained at ~1.3 x 10^8 PFU/ml. Thirty two samples of the Fluid Barrier Boot were tested according to the procedure described in this report All thirty two passed showing no ΦX174 on the assay plates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sloan Medical, Disposable Surgical Jumpsuit Associated Bag, Apron
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
FEB 2 5 1997
510(k) Summary of Safety and Effectiveness
| Submitter: | Instrument Makar, Inc
2950 E Mt. Hope Road
Okemos, MI 48864 | Date of Summary
K964364 | 2/20/97 |
|------------|-------------------------------------------------------------------|-----------------------------------------------------------------|---------|
| Phone: | (517)332-3593 | | |
| Fax: | (517)332-2043 | | |
| Contact: | Autumn Johnson | | |
| Product: | Classification Name:
Generic Name:
Trade/Proprietary Name: | Surgical Apparel (21 CFR 878.4040)
Apron
Disposable Apron | |
Substantially Equivalent Product:
Sloan Medical, Disposable Surgical Jumpsuit Associated Bag, Apron
Description:
The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a "onc size fits most" size The apron is secured by heing slipped over the head and tied in back
Intended Use:
The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healtheare worker from the transfer of micro-organisms. blood, body fluids and particulate material between the worker and the patient
The Disposable Apron is a disposable product intended for single use only.
Summary of the non-clinical tests from which substantinl equivalence:
The Disposable Apron has the sume intended use as Sloan Medical's Disposable Surgical Jumpsuit and Associated Bag's Apron. The designs are similar in that they both are scoured the neck and tied behind the back. The also cover the front of the following table summanzes the non-clinical tests from which the substantial equivalence is based.
1
| Sloan Medical | Associated Bag | Instrument Makar | |
|---|---|---|---|
| Jumpsur | Apron | Apron | |
| Intended Use | Protect user from fluids | ||
| in hospital environment | Protect user from fluids | ||
| in hospital environment | Protect user from fluids | ||
| in hospital environment | |||
| Design | Ties around the neck | ||
| and behind the back | Ties around the neck | ||
| and behind the back | Ties around the neck | ||
| and behind the back | |||
| Materials | 2 mil Polyethylene | 1 1/4 mil Polyethylene | 6 Gauge Embossed |
| Poly-Vinyl | |||
| Physical Safety | NA | NA | NA |
| Target Population | Hospital Personnel | Hospital Personnel | Hospital Personnel |
| Biocompatibility | Jumpsuit is worn over | ||
| clothing, therefore will | |||
| not be in contact with | |||
| user's skin | Apron is worn over | ||
| clothing, therefore will | |||
| not be in contact with | |||
| user's skin | Apron is worn over | ||
| clothing, therefore will | |||
| not be in contact with | |||
| user's skin | |||
| Anatomical Sites | Cover front of body and | ||
| feet | Cover front of body and | ||
| feet | Cover front of body and | ||
| feet | |||
| Additional Notes | Sold non-sterile | Sold non-sterile | Sold non-sterile |
Summary of the Viral Penetration Test: ASTM Method F1671-95
The matcrial from which the Apron is made, 6 gauge embossed Poly-Vinyl, is the same as Instrument Makar's Fluid Barrier Boots(K955835) are made
Summary:
:
The oX174 bacteriophage challenge suspension will be maintained at a concentration of at least 1.0 X 108 PFU/ml (plaque forming units/mL).
Test samples were propared by randomly cutting approximately 75mm x 75mm test swatches from the test material. Test samples were challenged with approximately 60 mL of a oX 174 bacteriophage suspension for 5 minutes at atmospheric pressure, 1 minute at 2.0 PSIG (13.8 kpa), and 54 minutes at atmospheric pressure or until liquid penetration was observed. At the conclusion of the test, the observed side of the test sample was rinsed with a sterile assay medium and then assayed for the presence of the oX 174 bacteriophings. The surface tension of the challenge suspension and the assay medium was adjusted to approximately 40-44 dynes/em using surf actant-type Tweents 80 at a final concentration of approximately 0.01% by volume.
These samples were also tested for computibility of materials and test organisms. This testing was done by placing a 10 uL aliquot of a 0X174 suspension containing a total of 900-1200 PFU near the center of the test sample after it had been clamped into the penetration test cell. After 60 minutes, the surface was rinsed with a sterile assay medium and then assayed for the presence of the oX174 bacteriophage
2
Results·
..............................................................................................................................................................................
. .. ..
The compatibility ratio for the Fluid Barner Boot was 1 3 - The challenge level was manitanced at -1.3 x 108 PFU/ml
Thirty two samples of the Fluid Barrier Boot were tested according to the procedure described in this report All thirty two passed showing no oX174 on the assay plates.