(137 days)
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No
The summary describes a kit of pre-packaged medical supplies and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device description states it is a kit bundling products for convenience and protection from fluids and chemicals, not for treating a disease or condition. The "intended use" also focuses on personal protection and cleanup procedures.
No
The device description indicates it is a kit bundling products for convenience and protection during procedures like spill clean-up or drug administration. It does not mention using the device to diagnose any condition.
No
The device description clearly states it is a kit containing physical, disposable items for procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for personal protection and convenience during procedures involving blood, body fluids, and chemicals. This is a protective and organizational function, not a diagnostic one.
- Device Description: The device is a kit containing pre-packaged, finished goods. There is no mention of analyzing samples from the human body to provide diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
The device is a collection of supplies for personal protection and convenience during procedures, not a tool for performing diagnostic tests.
N/A
Intended Use / Indications for Use
Combinations of products for the convenience and personal protection of the end user from blood, body fluids and chemicals while conducting specific procedures. The kits will include disposable, single use items for blood, drug or chemical spill clean up, drug preparation and/or drug administration.
Product codes
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Device Description
Procedure Specific kits are non-sterile kits that bundle or package together combinations of products for the convenience of the user. This saves the end user the time and effort of retrieving the individual products each time a procedure is performed.
Kit components are purchased as released finished goods in finished package form. To assemble a kit, individual products are selected, sealed in a polybag or other suitable container, and labeled with a contents label. If the finished package form is more than one unit, Sage will remove the number of units specified for the kit being assembled. The item will be repackaged in the kit without compromising the integrity of the product. There is no reprocessing of any of the components that would compromise an original intended use or alter its safety or effectiveness.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/2 description: The image shows the logo for SAGE Products Inc. Next to the logo is the number 8964168 written in cursive. The logo and number are both in black ink.
| Submitter Name | Karen Pinto, Regulatory Affairs Manager |
|---|---|
| Company Name | Sage Products Inc. |
| Street Address | 815 Tek Drive, Crystal Lake, IL 60014 |
| Contact Person | Karen Pinto, Regulatory Affairs Manager |
| Telephone of Contact Person | 815-455-4700 ext. 1383 |
| Fax of Contact Person | 815-455-5599 |
| Date of Summary Preparation | February 14, 1997 |
| Device Name | |
| Trade or Proprietary Name | Procedure Specific Kits |
| Common Name | Convenience kits |
| Classification Name | Convenience kits have not been classified |
| K Number | K964168 |
| Intended Use | Combinations of products for the convenience and |
| personal protection of the end user from blood, body | |
| fluids and chemicals while conducting specific | |
| procedures. The kits will include disposable, single use | |
| items for blood, drug or chemical spill clean up, drug | |
| preparation and/or drug administration. | |
| Response to 2/13/97 Requests Regarding Premarket Notification: Procedure Specific Kits | |
| Appendix 8, Page 1 of 2 | |
| "Innovative health care products since 1971" |
815 TEK DRIVE ■ P.O. Box 9693 ■ CRYSTAL LAKE, IL 60014-9693 815-455-4700 ■ 800-323-2220 ■ Fax: 815-455-5599
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Image /page/1/Picture/1 description: The image shows the logo for SAGE PRODUCTS INC. The word "SAGE" is written in large, bold, black letters. Below "SAGE" is a horizontal line, and below that is the text "PRODUCTS INC" in smaller letters. The logo is simple and easy to read.
-16 510(k) Summary (
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ការបរម្មណ៍ ប្រទេសកម្ពុជា នៅក្នុង និង ប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើប្រើ
Description
Procedure Specific kits are non-sterile kits that bundle or package together combinations of products for the convenience of the user. This saves the end user the time and effort of retrieving the individual products each time a procedure is performed.
Kit components are purchased as released finished goods in finished package form. To assemble a kit, individual products are selected, sealed in a polybag or other suitable container, and labeled with a contents label. If the finished package form is more than one unit, Sage will remove the number of units specified for the kit being assembled. The item will be repackaged in the kit without compromising the integrity of the product. There is no reprocessing of any of the components that would compromise an original intended use or alter its safety or effectiveness.
Substantial Equivalence Comparison
Some items which are convenience packed into the procedure specific kits are medical devices. These devices are pre-amendment devices exempt for pre-market notification or have been cleared per the pre-market notification process and have been found substantially equivalent to a predicate device.
The packaging of these commonly used devices will not affect the safety or effectiveness of the devices nor will the devices be marketed for a new or different indication for use.
Response to Requests Regarding Premarket Notification: Procedure Specific Kits Appendix 8, Page 2 of 2 "Innovative health care products since 1971"
815 TEK DRIVE = P.O. BOX 9693 = CRISTAL LAKE, IL 60014-9693 815-455-4700 ■ 800-323-2220 ■ Fax: 815-455-5599