TubeClear™ is indicated for use only and solely in clearing occlusions / clogs in nasogastric (NG) tubes (i.e., tubes that are placed through the nose and reside in the stomach) of adult patients. Clearing Stem Model NG-1036 is indicated for use in nasogastric tubes that are of size 10 - 14 French and have a length of 36 - 42 inches (91 - 108 cm). Clearing Stem Model NG-1043 is indicated for use in nasogastric tubes that are of size 10 - 18 French and have a length of 43 - 50 inches (109 - 127 cm).

Device Description

The Proposed Device is TubeClear. TubeClear is composed of a reusable Control Box and single use Clearing Stem. One Control Box model. Model 101 is used to actuate all Clearing Stem models. TubeClear has two Clearing Stem models, Models NG-1036 and NG-1043.

The Operator manually inserts the Clearing Stem into the feeding or decompression tube (i.e., Tube) and directs the Clearing Stem's advancement along the inside of the Tube. The Control Box Motor via electromechanical actuation creates a linear reciprocating motion. The linear reciprocating motion is transferred to the proximal end of the Clearing Stem which contains a Wire that also reciprocates. Because the Wire is continuous throughout the Clearing Stem, the reciprocating motion is further transferred to the distal Tip of the Wire. The motion at the Wire Tip mechanically acts on the occlusion, breaks up the occlusion and restores Tube patency.

Because the Control Box remains outside of the patient and it functions only to provide actuation to the Clearing Stem when the two are attached, the Clearing Stem is considered to be the primary element of TubeClear.

AI/ML Overview

Here’s a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Usability Testing	Passed all acceptance criteria
Retainability Testing	Passed all acceptance criteria
Operation and performance of the Control Box	Unaffected by design modification (removal of centimeter marks)
Performance of the Clearing Stem	Unaffected by design modification (removal of centimeter marks)
Shelf Life	Unaffected by design modification (removal of centimeter marks)
Biocompatibility	Unaffected by design modification (removal of centimeter marks)
Packaging and Transportation	Unaffected by design modification (removal of centimeter marks)
Software / Firmware	Unaffected by design modification (removal of centimeter marks)
Electromagnetic Compatibility / Electrical Safety	Unaffected by design modification (removal of centimeter marks)

2. Sample Size and Data Provenance for Test Set

The document mentions "Usability and Retainability testing by end users" but does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth of Test Set

The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. The testing described is "Usability and Retainability testing by end users," implying a user-centric evaluation rather than expert ground truthing in a diagnostic context.

4. Adjudication Method for Test Set

The document does not describe an adjudication method for the test set. Given the nature of the testing (usability and retainability), a formal adjudication process as seen in diagnostic studies would likely not be relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that an MRMC comparative effectiveness study was done, nor does it mention any effect size for human readers improving with or without AI assistance. This device is a mechanical medical device (TubeClear™), not an AI-powered diagnostic tool, so such a study would not be applicable.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone performance study. This device is a mechanical clearing system, not an algorithm, so a "standalone" or "algorithm only" performance study is not applicable.

7. Type of Ground Truth Used

The ground truth for the usability and retainability testing was based on "acceptance criteria" being met by "end users." This implies a subjective or objective assessment of the device's functionality and user interaction rather than a diagnostic accuracy ground truth like pathology or outcomes data.

8. Sample Size for Training Set

The document does not mention a training set as this device is a mechanical medical device and does not involve machine learning or AI models that require training data.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no training set for this type of medical device.

Summary

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

K123654 pg 1 of 4

Image /page/0/Picture/1 description: The image shows the logo for Actuated Medical. The logo consists of a stylized symbol to the left of the company name, "ACTUATEDMEDICAL". The symbol appears to be a stylized representation of a medical device or technology.

Innovative motion + Positive outcomes

310 Rolling Ridge Drive Bellefonte, PA 16823 + p (814) 355.0003 + f (814) 355.1532 +w ActuatedMedical.com

DEC 2 0 2012

- ISO 13485 & 14971
- 9001 Compliant
  - 1 WEF

Certified

ATTACHMENT 4

510(K) SUMMARY

summary of the Special 510(k) information is submitted in This accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR807.92.

510(k) Number:

4.1 APPLICANT INFORMATION

Date Prepared: November 5, 2012

Name and Address: Actuated Medical, Inc. 310 Rolling Ridge Drive Bellefonte, PA 16823 Ph: 814-355-0003 Fax: 814-355-1532

Contact Person:

Debora L. Demers, Ph.D., Director of QA/RA Ph: 814-355-0003 x112 Fax: 814-355-1532 Email: debora.demers@actuatedmedical.com

4.2 DEVICE INFORMATION

Classification: KNT TubeClear™ Trade Name: In Patient Nasogastric Tube Clearing System Common Name: Tubes, Gastrointestinal and Accessories, Classification Name: 21 C.F.R. §876.5980

Attachment 4, Pg. 1 of 4

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

4.3 PREDICATE DEVICE

TubeClear, manufactured by Actuated Medical, Inc. (AMI) and cleared under 510(k) K121571. is the Predicate Device. TubeClear is composed of a reusable Control Box and single use Clearing Stem. One Control Box model, Model 101 is used to actuate all Clearing Stem models. TubeClear has two Clearing Stem models, Models NG-1036 and NG-1043.

4.4 PROPOSED DEVICE DESCRIPTION

Attachment 4, Pg. 2 of 4

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

4.5 INDICATIONS FOR USE

tuatedMedical.com

The Proposed Device and the Predicate Device, have the exact same indications for use. TubeClear is indicated for use only and solely in clearing occlusions / clogs in nasogastric (NG) tubes (i.e., tubes that are placed through the nose and reside in the stomach) of adult patients. Clearing Stem Model NG-1036 is indicated for use in nasogastric tubes that are of size 10 - 14 French and have a length of 36 - 42 inches (91 -Clearing Stem Model NG-1043 is indicated for use in 108 cm). nasogastric tubes that are of size 10 - 18 French and have a length of 43 - 50 inches (109 - 127 cm).

4.6 TECHNOLOGICAL CHARACTERISTICS

The Proposed Device and the Predicate Device, have the exact same design features with one exception. The Predicate Device has pad printed centimeter markings on a 45 cm (18 in) segment of the Clearing Stem and the Proposed Device has NO pad printed centimeter markings on the 45 cm (18 in) segment of the Clearing Stem.

4.7 RISK ANALYSIS

The risk analysis methods used to assess the safety and efficacy impact of the design modification were Preliminary Hazard Analysis (PHA) and Failure Modes and Effects Analysis (FMEA). The Design Requirements Document, Design Input Output Matrix, and Finished Product Specification were also reviewed.

It was determined that the removal of centimeter marks did not add any new safety risk to TubeClear. The presence of centimeter markings is not a design requirement.

Attachment 4, Pg. 3 of 4

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

It was determined that the previously conducted design verification activities were still applicable. The proposed design modification will not affect the following:

1. Operation and performance of the Control Box.
1. Performance of the Clearing Stem.
1. Shelf Life.
1. Biocompatibility.
1. Packaging and Transportation.
1. Software / Firmware.
1. Electromagnetic Compatibility / Electrical Safety.

4.8 NON-CLINICAL PERFORMANCE DATA

Bench Testing focused on Usability Testing to support Design Validation. Usability and Retainability testing by end users passed all acceptance criteria.

4.9 CONCLUSIONS

The Proposed Device, TubeClear is substantially equivalent to the Predicate Device, TubeClear.

The Devices have the SAME:

1. Indications for Use.
1. Operating Principle.
1. Materials.
1. Construction.
1. Shelf Life.
1. Packaging.

Attachment 4, Pg. 4 of 4

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2012

Actuated Medical, Inc. % Debora L. Demers, Ph.D. Director, Quality Assurance and Regulatory Affairs 310 Rolling Ridge Drive BELLEFONTE PA 16823

Re: K123659

Trade/Device Name: TubeClear™ Model 101 Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: November 26, 2012 Received: November 30, 2012

Dear Dr. Demers:

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 for use based in the 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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of

{5}------------------------------------------------

Page 2 - Debora L. Demers, Ph.D.

medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire speethly advisor out FDA/Centers Offices/CDRH/CDRHOffices/ucm115809.htm for go to mtp.//www.radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation untilied CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

ATTACHMENT 2

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _K123659

Device Name: TubeClear™ Model 101

Indications for Use Statement

TubeClear™ is indicated for use only and solely in clearing occlusions / clogs in nasogastric (NG) tubes (i.e., tubes that are placed through the nose and reside in the stomach) of adult patients. Clearing Stem Model NG-1036 is indicated for use in nasogastric tubes that are of size 10 - 14 No-1050 is Indication 187 acc 18 - 42 inches (91 - 108 cm). Clearing Stem Preficit and have a longth of Sor use in nasogastric tubes that are of size Model NO-1040 10 have a length of 43 - 50 inches (109 - 127 cm).

Over-The-Counter Use AND/OR Prescription Use x (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2012.12.20 10:14:32 -05'00'

(Division Sign-Off) i. sion of Reproductive, Gastro-Renal, and rological Devices 510(k) Number 1123659

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.