PROCEDURE SPECIFIC KITS

K964168 · Sage Products, Inc. · FXX · Mar 3, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964168
• Device Name: PROCEDURE SPECIFIC KITS
• Applicant: Sage Products, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

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.

Device Story

Procedure Specific Kits; non-sterile bundles of pre-cleared, exempt, or pre-amendment medical devices; packaged in polybags or containers. Used by healthcare personnel to save time retrieving individual items for specific clinical procedures. Components remain in original finished state; no reprocessing or alteration of component safety/effectiveness. Benefits include improved workflow efficiency and protection from blood, body fluids, and chemicals.

Clinical Evidence

No clinical data; bench testing only (packaging/assembly verification).

Technological Characteristics

Non-sterile convenience kits; components are pre-cleared/exempt finished goods; packaging materials include polybags or suitable containers; no reprocessing of components.

Indications for Use

Indicated for healthcare personnel requiring personal protection and convenience during procedures involving blood, drug, or chemical spill cleanup, drug preparation, and drug administration.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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FEB 18 '97 03:42PM SAGE PRODUCTS INC
P.7/26
SAGE
PRODUCTS INC
K964168

# 16 510(k) Summary

MAR - 3 1997

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: [phone]

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FEB 18 '97 03:43PM SAGE PRODUCTS INC
P.8/26

# SAGE
PRODUCTS INC

## 16 510(k) Summary (Continued)

### 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, 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 • CRYSTAL LAKE, IL 60014-9693
815-455-4700 • 800-323-2220 • FAX: [phone]