The Sharps Shuttle and Sharp Shuttle with Locking Mechanism are single use, Sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc..

Device Description

The Sharps Shuttle and Sharps Shuttle with Locking Mechanism are injection or blow molded, single use, non-sterile, disposable, sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc. The Sharps Shuttles may be viewed as a portable sharps containment device that provides an alternative to the procedure of resheathing a needle with its original protective cover which is not a recommended practice or disposing of the sharp in a non-sharps container. The products are designed to hold sharps such as angio-caths, blood needles, lancets and small syringes.

The container is cylindrical for rigidness and has a conical taper. The product body is non colored translucent plastic and is approximately 6 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap which when snapped closed contains the biohazardous sharps for safe conveyance.

Locking and non locking versions are available. Both versions have a temporary closure which can be reopened for the placement of additional sharps prior to terminal disposal. In addition to the temporary closure, the locking Sharps Shuttle with Locking Mechanism can be permanently locked by engaging the locking tab.

Each unit is individually labeled with a biohazard label. Sharps Shuttles are available singly or packaged in a dispenser with an attached carrying handle for easy transport of unused containers. The dispenser is available for the storage of the device prior use. The dispenser does not function as an accessory for use, nor, is it intended to transport containers with biohazardous waste.

AI/ML Overview

The provided document, a 510(k) summary for the Sharps Shuttle, describes the device and its intended use, but does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for a medical AI/software device.

This 510(k) is for a physical medical device (a sharps container) and thus its "acceptance criteria" are related to product performance and safety, demonstrated through physical tests rather than a study with a test set, ground truth, or statistical performance metrics.

Therefore, many of the requested elements for an AI/software device study are not applicable to this document. I will extract the relevant information where possible and indicate when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Design Features" and their "Safety and Effectiveness Basis." These "Design Features" serve as the de facto acceptance criteria for this physical device, outlined by reference to OSHA regulations and general safety principles. The document describes the features but does not provide specific quantitative acceptance criteria values or detailed test results, only the basis for needing these features.

Design Feature	Acceptance Criteria (Basis)	Reported Device Performance
Impact Resistance	The container's ability to retain solid contents, following lid closure and locking, in the event it is dropped during handling/transport.	Not specified in this document.
Puncture Resistance	Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are puncture resistant. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, ii)	Not specified in this document.
Overfill Detection	During use, containers for contaminated sharps shall be replaced routinely and not be allowed to overfill. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, iii)	Not specified in this document. ("non-colored translucent plastic" might imply visibility for overfill)
Leak Resistance	Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are Leak Proof on sides and bottom. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii)	Not specified in this document.
Sharps Access & Closure	Contaminated sharps shall be discarded immediately or as soon as feasible in containers that are closable. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 1, i)	Not specified in this document. ("hinged cap which when snapped closed contains the biohazardous sharps")
Stability	During use, containers for contaminated sharps shall be maintained upright throughout use. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, ii)	Not specified in this document. ("cylindrical for rigidness")
Mounting Accessories	During use, containers for contaminated sharps shall be easily accessible to personnel and located as close as is feasible to the immediate area where sharps are used or can be reasonably anticipated to be found. (Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii, A, 2, i)	Not specified in this document.
Handling	Sharps containers should be safe and easy to handle in transport.	Not specified in this document.
Capacity	This value gives the user an estimate or comparison of volume.	"approximately 6 inches long by 1 inch in diameter"

Details of the "Study" (as applicable to a physical device 510(k)):

2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. For a physical device, this would typically involve testing a sample of manufactured units. The document only lists design features and their safety basis.
- Data provenance: Not applicable. This is not a data-driven device; its performance is assessed via physical testing against FDA/OSHA requirements for sharps containers. The document originates from Sage Products Inc. (Crystal Lake, IL, USA) and is a pre-market notification to the FDA in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context refers to the regulatory requirements for sharps containers (OSHA Bloodborne Pathogens Standard, 21 CFR 1910.1030), rather than expert consensus on interpretive data. The document implies compliance with these established regulations.
4. Adjudication method for the test set:
- Not applicable. Performance is likely determined by meeting defined physical test specifications, not by subjective expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical device, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the requirements of this device is based on regulatory standards and safety guidelines (specifically OSHA Bloodborne Pathogens Standard, 21 CFR 1910.1030) for physical sharps containers.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is a physical device, not an AI/software device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC" in smaller letters. The logo is simple and modern.

Pre-Market Notification: Sharps Shuttle 510K Summary- K972279

AUG 29 Bar

Identification of Applicant 1 Sage Products Inc. Company Name ................................................................................................................. A.. Karen Pinto Applicants Name .............................................................................................................................................................. B. Regulatory Affairs Manager 815 Tek Drive Street Address ............................................................................................................................................................... C. Crystal Lake, IL 60014 Address(es) of Manufacturing Site(s) .. Sage Products Inc. D. 815 Tek Drive Crystal Lake, IL 60014 Address(es) of Sterilizing Site(s).......... N/A-Product in non-sterile ய் June 17, 1997 Date of Application .......................................................................................................................................................... r.

2 Device

A	Trade or Proprietary Name	Sharps Shuttle/Sharps Shuttle with LockingMechanism
B	Common Name	Sharps Container
C	Classification Name	Accessory to Hypodermic Single Lumen Needle(CFR: 880.5570)
E.	Classification	II
F.	Panel	80
G.	Procodes	FMI

Section 10, page 16 of 18 of Submission Revised per 8/20/97 request

page 1 of 3 of Summary

"Innovative health care products since 1971"

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Image /page/1/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The logo is in black and white, with the word "SAGE" in large, bold letters. Below the word "SAGE" is the phrase "PRODUCTS INC." in smaller letters. The logo is simple and modern.

Pre-Market Notification: Sharps Shuttle 510K Summary- K972279

General Description 3

Substantial Equivalence 4

Predicate Devices for Sage Products, Inc. Sharps Shuttle A.

BD Home Sharps Container by Med-Safe Systems, Inc
One Quart Sharps Container by Sage Products, Inc.
SHARP-SAFE by Smiths Industries Medical Systems
STIC-KIT by Emergency Medical Innovations, Inc.

B. Rationale Discussion

In summary, all five products are plastic, non-sterile, disposable, portable, sharps transport containers intended for use in various field situations. All the devices allow for one handed disposal of sharps and offer a means of closure.

Section 10, page 17 of 18 of Submission Revised per 8/20/97 request

"Innovative health care products since 1911"

page 2 of 3 of Summary

815 TEK DRIVE . P.O. BOX 9693 . CRYSTAL LAKE. IL 60039-9693 815-455-4700 ■ 800-323-2220 ■ Fax: 815-455-5599

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Image /page/2/Picture/2 description: The image shows the logo for SAGE PRODUCTS INC. The word "SAGE" is in large, bold, sans-serif font. Below the word "SAGE" is the text "PRODUCTS INC" in a smaller, sans-serif font. There is a horizontal line that extends from the left of the word "PRODUCTS" to the right of the word "INC".

Pre-Market Notification: Sharps Shuttle 510K Summary- K972279

Design Features 5

Design Feature	Safety and Effectiveness Basis
Impact Resistance	The impact resistance test will provide information about the containers ability toretain solid contents, following lid closure and locking, in the event it is droppedduring handling/transport.
PunctureResistance	Contaminated sharps shall be discarded immediately or as soon as feasible incontainers that are puncture resistant. Ref: OSHA Bloodborne Pathogens 21CFR 1910.1030, d, 4, iii, A, 1, ii
Overfill Detection	During use, containers for contaminated sharps shall be replaced routinely andnot be allowed to overfill. Ref: OSHA Bloodborne Pathogens 21 CFR1910.1030, d, 4, iii, A, 2, iii
Leak Resistance	Contaminated sharps shall be discarded immediately or as soon as feasible incontainers that are Leak Proof on sides and bottom. Ref: OSHA BloodbornePathogens 21 CFR 1910.1030, d, 4, iii, A, 1, iii.
Sharps Access andClosure	Contaminated sharps shall be discarded immediately or as soon as feasible incontainers that are closable. Ref: OSHA Bloodborne Pathogens 21 CFR1910.1030, d, 4, iii, A, 1, i
Stability	During use, containers for contaminated sharps shall be maintained uprightthroughout use. Ref: OSHA Bloodborne Pathogens 21 CFR 1910.1030, d, 4, iii,A, 2, ii
MountingAccessories	During use, containers for contaminated sharps shall be easily accessible topersonnel and located as close as is feasible to the immediate area where sharpsare used or can be reasonably anticipated to be found. Ref: OSHA BloodbornePathogens 21 CFR 1910.1030, d, 4, iii, A, 2, i
Handling	Sharps containers should be safe and easy to handle in transport.
Capacity	This value gives the user an estimate or comparison of volume.

Section 10, page 18 of 18 of Submission Revised per 8/20/97 request

page 3 of 3 of Summary

"Innovaave health care products since 1971"

815 TEK DRIVE ▪ P.O. Box 9693 ▪ CRY:TAL LAKE. IL 60039-9693 128 - 300-323-2220 = Fax: 815-455-5599

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Image /page/3/Picture/2 description: The image shows a logo with text and a stylized graphic. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the graphic. The graphic consists of three stylized human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 29 1997

Ms. Karen Pinto Regulatory Affairs Manager Sage Products, Incorporated 815 Tek Drive Crystal Lake, Illinois 60014-9693

K972279 Re: Sharps Shuttle and Sharps Shuttle with Trade Name: Locking Mechanism Regulatory Class: II FMI Product Code: Dated: June 17, 1997 Received: June 18, 1997

Dear Ms. Pinto:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Cood Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, chrough periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Pinto

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Alidatoust

Timot A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Aug. 20. 1997 1 : 42PM SAGE PRODUCTS INC No. 4313 . 3/5

Page_ 1 of 1

510(k) Number (if known): K972279

Sharps Shuttle and Sharps Shuttle with Locking Mechanism Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Sharps Shuttle and Sharp Shuttle with Locking Mechanism are single use, I he Sharps Shutter and Sharps transport containers intended for use in any setting where standard sharps containers are not conveniently accessible, such as EMS, home health care, etc..

[Section 9, Page 15 of 18 of Response to 8/20/97 Request for Additional Information [occaon >> Ret Notification Submission. Sharps Shuttle]

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K972279

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional Format 1-2-96)

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).