(137 days)
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.
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.
This document is a 510(k) Summary for "Procedure Specific Kits" from Sage Products Inc., dated February 14, 1997. It describes convenience kits that bundle various products for specific medical procedures.
Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets acceptance criteria in the manner requested (i.e., performance metrics, sample sizes, expert ground truth, etc.).
The document focuses on the description of the device as non-sterile convenience kits, the process of assembling them, and their substantial equivalence to predicate devices under the pre-market notification process.
Here's why the requested information cannot be provided from this text:
- Type of Device: The "device" in question is a "convenience kit" or a "procedure specific kit." These are essentially repackaged collections of existing, cleared or pre-amendment medical devices. The document explicitly states: "There is no reprocessing of any of the components that would compromise an original intended use or alter its safety or effectiveness."
- Regulatory Pathway: The submission is a 510(k) pre-market notification, which seeks to demonstrate substantial equivalence to a predicate device. It is not a submission for a novel, high-risk device requiring extensive clinical trials or performance studies with the detailed metrics you've asked for.
- Focus of the Document: The content emphasizes that the individual components bundled in the kits are already cleared or exempt devices, and the packaging of these components does not affect their safety or effectiveness.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, expert involvement, or AI performance because the provided document does not contain this type of information. It falls outside the scope of this particular 510(k) submission, which is more about administrative bundling of pre-existing, cleared components rather than demonstrating novel device performance.
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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 andpersonal protection of the end user from blood, bodyfluids and chemicals while conducting specificprocedures. The kits will include disposable, single useitems for blood, drug or chemical spill clean up, drugpreparation and/or drug administration. |
| Response to 2/13/97 Requests Regarding Premarket Notification: Procedure Specific KitsAppendix 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.
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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
§ 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.