POCKET COUNT OR SAFETCOUNT

K972302 · Sage Products, Inc. · LWH · Jul 25, 1997 · General Hospital

Device Facts

• Record ID: K972302
• Device Name: POCKET COUNT OR SAFETCOUNT
• Applicant: Sage Products, Inc.
• Product Code: LWH · General Hospital
• Decision Date: Jul 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2740
• Device Class: Class 1

Intended Use

Containment and Counting of Sponges in the Operating Room or a hospital setting.

Device Story

Pocket Count and SafeTCount are disposable, transparent surgical sponge management devices used in operating rooms and hospital settings. Pocket Count is a compartmentalized bag; SafeTCount is a hand-shaped covering. Both devices allow visual confirmation of sponge counts and visual estimation of absorbed fluids. They provide partial containment of contaminated sponges to reduce healthcare worker exposure to contents. The devices are used by hospital staff to collect and contain sponges during surgical procedures. They do not involve electronic processing or automated analysis.

Clinical Evidence

No clinical data. The device relies on bench-level performance comparisons regarding material, design, and capacity (holding up to 5 lap sponges or 10 4x4 sponges) against predicate devices.

Technological Characteristics

Materials: Polyethylene. Form factor: Transparent, disposable bags (Pocket Count) or hand-shaped coverings (SafeTCount). Connectivity: None. Sterility: Non-sterile. Energy source: None. Software: None.

Indications for Use

Indicated for the containment and counting of surgical sponges in the operating room or hospital setting for healthcare personnel.

Regulatory Classification

Identification

A surgical sponge scale is a nonelectrically powered device used to weigh surgical sponges that have been used to absorb blood during surgery so that, by comparison with the known dry weight of the sponges, an estimate may be made of the blood lost by the patient during surgery.

Predicate Devices

• Bag-It (Devon)
• Multi-Mitt (Devon)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2006

SAGE Products, Inc. c/o Ms. Karen Pinto Regulatory Affairs Manager 815 Tek Drive, P.O. Box 9693 Crystal Lake, Illinois 60039-9693

Re: K972302 Trade/Device Name: Pocket Count or SafeTCount Regulation Number: 21 CFR 880.2740 Regulation Name: Surgical sponge scale Regulatory Class: I Exempt Product Code: LWH Dated: June 18, 1997 Received: June 19, 1997

Dear Ms. Pinto:

This letter corrects our substantially equivalent letter of July 25, 1997.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act`s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21

{1}------------------------------------------------

Page 2 – Ms. Karen Pinto

CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

l.mll.

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The word "SAGE" is in large, bold, black letters. Below the word "SAGE" is the word "PRODUCTS INC" in smaller, black letters. Above the logo is the number "K972302" in black handwriting.

JUL 25 1997

| 17 | 510(k) Summary |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name | Sage Products Inc. |
| Street Address | 815 Tek Drive, Crystal Lake, IL 60014 |
| Date of Summary Preparation | June 18, 1997 |
| Device Name | |
| Trade or Proprietary Name | Pocket Count or SafeTCount |
| Common Name | Surgical Sponge Counter (CFR designation does not exist) |
| Classification Name | Sponge Counter |
| Intended Use | Containment and Counting of Sponges |
| Description | |
| Pocket Count | Transparent, compartmentalized, disposable bag which allows<br>visual confirmation of sponge count and visual estimate of<br>absorbed fluid. Pocket Count provides partial containment of<br>contaminated sponges, thereby, decreasing worker exposure to<br>contents. |
| SafeTCount | Transparent, disposable hand shaped covering which is used to<br>collect sponges. When the covering is turned inside out it<br>contains the contaminated sponges thereby decreasing worke |

Section 17, page 12 of 13 of Submission

Page 1 of 2 of Summary

"Innovative health care products since 1971"

fluid.

exposure to contents. The SafeTCount allows visual

confirmation of sponge count and visual estimate of absorbed

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for SAGE PRODUCTS INC. The word "SAGE" is written in large, bold, sans-serif font, with each letter having a slightly futuristic or stylized design. Below "SAGE", the words "PRODUCTS INC" are written in a smaller, sans-serif font. A horizontal line spans the length of the words "PRODUCTS INC".

## 510(K)

## Substantial Equivalence Comparison

ﻟﻤﺴﺘﻌﻤﻞ

ﺔ ﻣﻦ ﺍﻟ

| Product Name | Pocket Count | Bag-It | SafeTCount | Multi-Mitt |
|---------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|-------------------------------------|
| Manufacturer | Sage Products | Devon | Sage Products | Devon |
| Intended Use of Product | Containment and counting of sponges | Containment and counting of sponges | Containment and counting of sponges | Containment and counting of sponges |
| Design | compartmentalized pockets | compartmentalized pockets | hand shaped hand covering | rectangular hand covering |
| Pull Tabs | Available | Not available | N/A | N/A |
| Material | Polyethylene | Polyethylene | Polyethylene | Polyethylene |
| Clarity | Transparent | Transparent | Transparent | Transparent |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Target Population | OR/Hospital | OR | OR/Hospital | Hospital |
| Compliance with Standards | N/A | N/A | 21 CFR 800.20 | 21 CFR 800.20 |
| Performance | Holds up to 5 lap sponges or 10 - 4x4's | Holds up to 5 lap sponges or 10 - 4x4's | Holds up to 5 lap sponges or 10 - 4x4's | No Claim Made |
| Accessories Available | Bracket for mounting | Bracket for mounting | Bracket for mounting | Bracket for mounting |

Section 17, page 13 of 13 of Submission

Page 2 of 2 of Summary

"Innovative health care products since 1971"

{4}------------------------------------------------

| 510(k) Number (if known): | K97 23 02 |
|---------------------------|-----------|
|---------------------------|-----------|

Device Name: Sponge Counter_

Indications For Use:

Containment and Counting of Sponges in the Operating Room or a hospital setting.

Section 16, page 11 of 13 of submission

(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 X

(Optional Format 1-2-96)