(26 days)
Not Found
No
The device description details a purely mechanical and electromechanical mechanism for clearing tube occlusions. There is no mention of any computational analysis, learning, or adaptive behavior that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is described as clearing occlusions/clogs in feeding and decompression tubes in adults, which directly addresses a medical condition impacting a patient's health and well-being. This qualifies it as a therapeutic device.
No
The device is designed to clear occlusions/clogs in feeding and decompression tubes. It does not provide any diagnostic information about the patient's condition or the nature of the occlusion. Its function is entirely therapeutic/interventional.
No
The device description explicitly states it is comprised of a "Control Box Model 101 and Clearing Stem Models TC-0608, TC-0812, and TC-1018," which are physical hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to clear occlusions/clogs in feeding and decompression tubes in adults. This is a mechanical intervention performed in vivo (within the patient's body), not on samples in vitro (outside the body).
- Device Description: The device description details a mechanical system (Control Box and Clearing Stem with a reciprocating wire) that is manually inserted into a tube while the tube remains in the patient. This is a physical action to restore patency, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health condition.
Therefore, the TubeClear Clearing Stem is a medical device used for a therapeutic/interventional purpose, not an IVD.
N/A
Intended Use / Indications for Use
TubeClear Clearing Stem Model TC-1018 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type and size (French and length).
- TC-1018. for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 91 - 140 cm (36 - 55 in); and Gastrostomy and Jejunostomy Tubes that are size 10 - 18 Fr and have a length of 20 - 36 cm (8 - 14 in).
TubeClear Clearing Stem Model TC-0812 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.
- TC-0812, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in).
TubeClear Clearing Stem Model TC-0608 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.
- TC-0608, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 -140 cm (15 - 55 in).
Product codes
KNT
Device Description
The Proposed Device, the TubeClear Control Box and Clearing Stem, is comprised of Control Box Model 101 and Clearing Stem Models TC-0608, TC-0812, and TC-1018. The Control Box is reusable and the Clearing Stems are single use. The Operator manually inserts the Clearing Stem into the feeding and/or decompression tube (i.e., Tube), while the Tube remains in the Patient, and directs the Clearing Stem's progression 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 and restores Tube patency.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal (GI) system
Indicated Patient Age Range
adults
Intended User / Care Setting
Certified or Licensed Healthcare Practitioners.
Patient's bedside location (e.g., hospital, non-acute care facility, Patient's home).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench Testing of the Clearing Stem focused in three areas: Technical, Efficacy, and Safety.
Technical testing included verification of product specifications, Wire tip flexibility, forces on Clearing Stem, distal Wire pull force, accelerated shelf life, and packaging integrity / transportation vibration.
Efficacy testing included Human Factors Validation and comparison of device effectiveness.
Safety testing evaluated the potential for Tube damage (i.e., Tube Heating and Integrity), Tube movement during use of TubeClear, and Operator error coupled with abnormal use.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
As the same Control Box (i.e., Model 101) is used with the Proposed and Predicate Clearing Stem Models, testing presented in this submission focused predominantly on the Clearing Stem. Bench Testing of the Clearing Stem focused in three areas: Technical, Efficacy, and Safety.
Technical Testing: Verification confirmed that the Clearing Stem Models met product specifications and all acceptance criteria. Transportation vibration testing met all acceptance criteria for US highway truck. Shelf life was tested via accelerated shelf life testing and met all acceptance criteria for 12 month storage. Additional testing for longer shelf life is ongoing.
Efficacy Testing: Human Factors Validation testing by certified and licensed healthcare practitioners was successfully completed. Evaluation of effectiveness during simulated use was performed for the Proposed Clearing Stem Models and compared to the effectiveness of the Predicate Clearing Stem Models. Human Factors Validation and comparison of device effectiveness testing results support substantial equivalence of effectiveness of the Proposed and Predicate Devices.
Safety Testing: Safety testing for the Proposed and Predicate Clearing Stem Models included an assessment of Tube Integrity, Tube Heating, and Tube movement. Effect of Clearing Stem on Tube Integrity (e.g., scratches, nicks, tears, abrasions, punctures to the inner tube surface) was found to be substantially equivalent for both Devices use of TubeClear. Tube heating was found to be negligible and substantially equivalent for both Devices during use of TubeClear. Tube movement was found to be substantially equivalent for both Devices during use of TubeClear. A third-party organization (Intertek Group (Boxborough, MA)) tested and found conformance to general requirements for basic safety and essential performance for medical electrical equipment, application of usability engineering, and ISO 14971 risk management framework as per consensus standards IEC-60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), IEC 60601-1-6: 2010, and IEC 62366: 2007. The third-party organization also tested and found Electromagnetic Compatibility conformance as per consensus standard IEC 60601-1-2:2001 +A1:2004. Safety testing results support substantial equivalence of safety of the Proposed and Predicate Devices.
Animal Testing: Animal testing was carried out to assess the probability that the Proposed Clearing Stem Models would puncture the intestinal lining of the patient in the event that the Clearing Stem is over-inserted into the tube. Forces generated by the worst case scenario (Depth Limiter set so Working Length is longer than Tube length) coupled with abnormal use (excessive force) on porcine jejunum tissue were analyzed on a force gauge to determine a reasonable assurance of safety. Animal Testing results support that the Proposed Clearing Stem Design is safe for its intended use in adult patient populations and substantially equivalent to the Predicate Clearing Stem Design in terms of safety if Operator Error Coupled with Abnormal Use were to occur.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three heads in profile, facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 30, 2016
Actuated Medical, Inc. % Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041
Re: K163092
Trade/Device Name: TubeClear Control Box and Clearing Stem Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: Class II Product Code: KNT Dated: November 2, 2016 Received: November 4, 2016
Dear Dave Yungvirt,
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 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 medical device
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Joyce M. Whang -S
for 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
2
Indications for Use
510(k) Number (if known)
K163092
Device Name TubeClear Control Box and Clearing Stem
Indications for Use (Describe)
TubeClear Clearing Stem Model TC-1018 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type and size (French and length).
· TC-1018. for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 91 - 140 cm (36 - 55 in); and Gastrostomy and Jejunostomy Tubes that are size 10 - 18 Fr and have a length of 20 - 36 cm (8 - 14 in).
TubeClear Clearing Stem Model TC-0812 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.
· TC-0812, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in).
TubeClear Clearing Stem Model TC-0608 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.
· TC-0608. for Nasoenteral and Nasogastric Tubes composed of Polyviny) Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 -140 cm (15 - 55 in).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Actuated Medical. The logo consists of the words "ACTUATED" in gray and "MEDICAL" in orange, with a stylized orange cross to the left of the word "ACTUATED". Below the logo is the tagline "Innovative motion + Positive outcomes" in gray.
310 Rolling Ridge Drive Bellefonte, PA 16823 + p (814) 355.0003 + f (814) 355.1532 ActuatedMedical.com
Operating As ...
-
- ISO 13485:2003 Certified
-
- ISO 14971:2007 Compliant
-
- Women-Owned Certified
SECTION 5: 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92
510(k) Number:
5.1: Applicant Information
| Date Prepared: | November 30, 2016 |
|---|---|
| Name and Address: | Actuated Medical, Inc. |
| 310 Rolling Ridge Drive | |
| Bellefonte, PA 16823 | |
| Ph: (814) 355-0003 | |
| Fx: (814) 355-1523 | |
| Contact Person: | Katherine M. Erdley |
| Director Quality Assurance | |
| Ph: (814) 355-0003 x116 | |
| Fx: (814) 355-1523 | |
| Email: Katherine.Erdley@actuatedmedical.com |
5.2: Device Information
| Classification: | KNT |
|---|---|
| Trade Name | TubeClear Control Box and Clearing Stem |
| Common Name: | In Patient Tube Clearing System |
| Classification Name: | Tube, Gastrointestinal and Accessories, |
| 21 C.F.R. §876.5980 | |
| Control Box Model: | 101 |
| Clearing Stem Models: | TC-0608, TC-0812, and TC-1018 |
Image /page/3/Picture/13 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange, transitioning from a lighter shade to a darker one. A pattern of squares in alternating shades of orange creates a checkerboard effect. A wavy line in a lighter shade of orange meanders across the image, adding a sense of movement and fluidity to the composition.
4
Image /page/4/Picture/1 description: The image is a close-up of an orange background with a pattern of lighter orange squares. The squares are arranged in a staggered pattern, creating a visually interesting texture. A wavy line runs across the squares. The overall effect is a warm and inviting design.
5.3: Predicate Device
The legally marketed device to which substantial equivalence is being claimed:
| 510(k) Number | Trade Name | Manufacturer |
|---|---|---|
| K131052 | TubeClear | Actuated Medical, Inc. |
The Predicate Device, TubeClear, is comprised of Control Box Model 101 and Clearing Stem Models NE-1036, NE-1042, NE-1043, NE-1045, NE-1048, NE-1050, NE-1055, G-1008, G-1009, G-1010, G-1011, G-1012, and G-1014.
5.4: Device Description
The Proposed Device, the TubeClear Control Box and Clearing Stem, is comprised of Control Box Model 101 and Clearing Stem Models TC-0608, TC-0812, and TC-1018. The Control Box is reusable and the Clearing Stems are single use. The Operator manually inserts the Clearing Stem into the feeding and/or decompression tube (i.e., Tube), while the Tube remains in the Patient, and directs the Clearing Stem's progression 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 and restores Tube patency.
Three (3) new Clearing Stem Models are proposed. The additional Clearing Stem Models expand the specific indications for use.
5.5 Intended Use
The Proposed Clearing Stem Models are substantially equivalent to the Predicate Clearing Stem Models in regards to intended use and therapeutic The intended use is to clear occlusions/clogs from feeding and effect. decompression tubes (i.e., Tubes). For both the Proposed and Predicate Clearing Stem Models, the therapeutic effect is to restore Tube patency and alleviate the need for Tube replacement.
5
Image /page/5/Picture/1 description: The image is an abstract design featuring a gradient of orange hues. The left side of the image is a solid, darker shade of orange, which gradually transitions into a lighter, patterned area on the right. This patterned area consists of a grid-like arrangement of squares in alternating shades of orange, creating a checkerboard effect. Overlaying this grid is a series of wavy lines in a lighter orange, adding a dynamic and flowing element to the geometric background.
Both the Proposed and Predicate Clearing Stem Models are disposable, single use devices. The Proposed Clearing Stem Models are intended for use by Certified or Licensed Healthcare Practitioners. The Predicate Clearing Stem Models are intended for use by Licensed Healthcare Practitioners. Human Factors Validation testing results support substantial equivalence of the expanded User group.
Both the Proposed and Predicate Clearing Stem Models are intended for use at the Patient's bedside location (e.g., hospital, non-acute care facility, Patient's home). The intended use locations support substantially equivalence of the use environment.
Both the Proposed and Predicate Clearing Stem Models enter a Tube that is within the Patient, no Model makes direct contact with the Patient. Both the Proposed and Predicate Clearing Stem Models are placed in a Tube that is in the Patient's gastrointestinal (GI) system. Both the Proposed and Predicate Clearing Stem Models do not require sterile conditions for their intended purpose.
5.6 Indications for Use
5.6.1: Specific Indications for Use of the Proposed Clearing Stem Models
TubeClear Clearing Stem Model TC-1018 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type and size (French and length).
-
. TC-1018. for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 91 - 140 cm (36 - 55 in); and Gastrostomy and Jejunostomy Tubes that are size 10 - 18 Fr and have a length of 20 - 36 cm (8 - 14 in).
TubeClear Clearing Stem Model TC-0812 is indicated for use ONLY and SOLELY in clearing occlusion / clogs in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material. -
. TC-0812. for Nasoenteral and Nasoqastric Tubes composed of Polyvinyl Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in).
Image /page/5/Picture/11 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange, transitioning from a solid color to a pattern of squares. A wavy line meanders across the image, adding a dynamic and fluid contrast to the structured background.
6
Image /page/6/Picture/1 description: The image is a background with a pattern of orange squares and squiggly lines. The squares are arranged in a checkerboard pattern, with alternating light and dark orange squares. The squiggly lines are a lighter shade of orange and run diagonally across the squares. The background is mostly orange, with a small white strip at the bottom.
TubeClear Clearing Stem Model TC-0608 is indicated for use ONLY and SOLELY in clearing occlusion / cloas in Feeding and Decompression Tubes in adults that have the following Tube type, size (French and length), and material.
- TC-0608, for Nasoenteral and Nasogastric Tubes composed of Polyvinyl . Chloride (PVC) and Polyurethane that are size 6 - 8 Fr and have a length of 38 -140 cm (15 - 55 in).
5.6.2: Specific Indications for Use of the Predicate Clearing Stem Models
TubeClear is indicated for use ONLY and SOLELY in clearing occlusions / clogs in Feeding and Decompression Tubes in adult patients that have a Tube of size 10 to 18 Fr.
The Clearing Stem Models are indicated for use as follows:
NE-1036, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 91 cm (36 in).
NE-1042, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 107 cm (42 in).
NE-1043, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 109 cm (43 in).
NE-1045, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 114 cm (45 in).
NE-1048, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 122 cm (48 in).
NE-1050, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 127 cm (50 in).
NE-1055, for Nasoenteral and Nasogastric Tubes that are of size 10 - 18 Fr and have a length of 140 cm (55 in).
G-1008, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 20 cm (8 in).
7
Image /page/7/Picture/1 description: The image is a background with a pattern. The left side of the image is a solid orange color. The right side of the image has a checkerboard pattern in two shades of orange, with a wavy line drawn over it.
G-1009, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 23 cm (9 in).
G-1010, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 25 cm (10 in).
G-1011, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 28 cm (11 in).
G-1012, for Gastrostomy and Jejunostomy Tubes that are of size 10 - 18 Fr and have a length of 30 cm (12 in).
G-1014, for Gastrostomy and Jejunostomy Tubes that are of size 10- 18 Fr and have a length of 36 cm (14 in).
The specific indications for use vary from Clearing Stem Model to Clearing Stem Model; however, the differences are not critical to the intended therapeutic use of the device, which is restoring patency to the Tube and alleviating the need for Tube replacement. The differences do not affect the safety and effectiveness of the Proposed Clearing Stem Models.
5.7: Technological Characteristics
The technological characteristics of the Proposed Device are similar to the Predicate Device. Both the Proposed and Predicate Devices have the same operating principle (i.e., Operator interaction with the Device and the Clearing Stem Wire mode of actuation). Both the Proposed and Predicate Clearing Stem Models are manually inserted and advanced into the Patient's Tube. Both the Proposed and Predicate Clearing Stem Models physically interact with the occlusion material inside a Tube. Both the Proposed and Predicate Clearing Stem Models mechanically clear occlusions restoring Tube patency.
The design features of the Proposed Device are similar to the Predicate Device. Both the Proposed and Predicate Clearing Stem Models are single use. Both the Proposed and Predicate Clearing Stem Models have rounded and flexible Wire Tips. Both the Proposed and Predicate Clearing Stems have multiple Models differentiated by color. Both the Proposed and Predicate Clearing Stem Models have informative labeling. Both the Proposed and Predicate Clearing Stem
8
Image /page/8/Picture/1 description: The image is a background with a pattern of orange squares and a wavy line. The squares are arranged in a checkerboard pattern, with alternating light and dark orange squares. The wavy line is a darker shade of orange and runs diagonally across the image. The background is a solid orange color.
Models have a depth limiting component that determines the Working Length (i.e., the length of the Clearing Stem that can be inserted into the Tube).
The method of attachment of the depth limiting component is different between the Proposed and Predicate Devices. The Proposed Device depth limiting component (i.e., Depth Limiter) is attached to the Clearing Stem Model by the Operator. The Predicate Device depth limiting component (i.e., Collar) is attached to the Clearing Stem Model by the Manufacturer.
Performance data and Human Factors Validation testing results support substantial equivalence of the technological characteristics of the Proposed and Predicate Devices.
5.8: Non-Clinical Performance Data
As the same Control Box (i.e., Model 101) is used with the Proposed and Predicate Clearing Stem Models, testing presented in this submission focused predominantly on the Clearing Stem. Bench Testing of the Clearing Stem focused in three areas: Technical, Efficacy, and Safety. Technical testing included verification of product specifications, Wire tip flexibility, forces on Clearing Stem, distal Wire pull force, accelerated shelf life, and packaging integrity / transportation vibration. Efficacy testing included Human Factors Validation and comparison of device effectiveness. Safety testing evaluated the potential for Tube damage (i.e., Tube Heating and Integrity), Tube movement during use of TubeClear, and Operator error coupled with abnormal use.
5.8.1: Technical Testing
Verification confirmed that the Clearing Stem Models met product specifications and all acceptance criteria. Transportation vibration testing met all acceptance criteria for US highway truck. Shelf life was tested via accelerated shelf life testing and met all acceptance criteria for 12 month storage. Additional testing for longer shelf life is ongoing.
5.8.2: Efficacy Testing
Human Factors Validation testing by certified and licensed healthcare practitioners was successfully completed. Evaluation of effectiveness during
9
Image /page/9/Picture/1 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange hues, with the left side being a solid, darker shade that gradually transitions to a lighter, patterned area on the right. The pattern consists of a grid-like arrangement of squares or rectangles in alternating shades of orange, creating a checkerboard effect. Overlaying this geometric pattern are wavy lines in a lighter orange, adding a sense of movement and fluidity to the composition.
simulated use was performed for the Proposed Clearing Stem Models and compared to the effectiveness of the Predicate Clearing Stem Models.
Human Factors Validation and comparison of device effectiveness testing results support substantial equivalence of effectiveness of the Proposed and Predicate Devices.
5.8.3: Safety Testing
Safety testing for the Proposed and Predicate Clearing Stem Models included an assessment of Tube Integrity, Tube Heating, and Tube movement. Appropriate safety tests were determined using AMI's ISO 14971-compliant system's risk management activities. Effect of Clearing Stem on Tube Integrity (e.g., scratches, nicks, tears, abrasions, punctures to the inner tube surface) was found to be substantially equivalent for both Devices use of TubeClear. Tube heating was found to be negligible and substantially equivalent for both Devices during use of TubeClear. Tube movement was found to be substantially equivalent for both Devices during use of TubeClear.
A third-party organization (Intertek Group (Boxborough, MA)) tested and found conformance to general requirements for basic safety and essential performance for medical electrical equipment, application of usability engineering, and ISO 14971 risk management framework as per consensus standards IEC-60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), IEC 60601-1-6: 2010, and IEC 62366: 2007. The third-party organization also tested and found Electromagnetic Compatibility conformance as per consensus standard IEC 60601-1-2:2001 +A1:2004.
Safety testing results support substantial equivalence of safety of the Proposed and Predicate Devices.
5.8.4 Animal Testing
Animal testing was carried out to assess the probability that the Proposed Clearing Stem Models would puncture the intestinal lining of the patient in the event that the Clearing Stem is over-inserted into the tube. Forces generated by the worst case scenario (Depth Limiter set so Working Length is longer than Tube length) coupled with abnormal use (excessive force) on porcine jejunum tissue were analyzed on a force gauge to determine a reasonable assurance of
10
Image /page/10/Picture/1 description: The image is an abstract design featuring shades of orange. The background consists of a pattern of squares in alternating shades of orange, creating a textured effect. Overlaying this pattern are wavy lines, also in a lighter shade of orange, adding a dynamic element to the composition.
safety. Animal Testing results support that the Proposed Clearing Stem Design is safe for its intended use in adult patient populations and substantially equivalent to the Predicate Clearing Stem Design in terms of safety if Operator Error Coupled with Abnormal Use were to occur.
5.9: Clinical Performance Data
No clinical data was collected; therefore, no clinical data is presented in this submission.
5.10: Conclusions
The scientific data demonstrates that the Proposed Clearing Stem Models are substantially equivalent to the Predicate Clearing Stem Models. The 510(k) Substantial Equivalence Decision Making Process Flow Chart was used by Actuated Medical, Inc. to determine Substantial Equivalence.