(309 days)
Not Found
No
The description focuses on a mechanical system for clearing tubes, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as "clearing occlusions/clogs in Feeding and Decompression Tubes in adult patients," which implies a direct therapeutic effect by restoring the patency of essential medical tubes.
No
The device is intended to clear occlusions in feeding and decompression tubes and restore patency, which is a treatment or remediation action rather than a diagnostic one.
No
The device description explicitly states the system is comprised of a reusable Control Box and a single-use Clearing Stem, which are hardware components. The Control Box actuates the Clearing Stem Wire, indicating a mechanical action, not purely software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TubeClear System is designed to mechanically clear blockages in feeding and decompression tubes within the patient's body. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states its purpose is to clear occlusions/clogs in tubes used for feeding and decompression in adult patients. This is a therapeutic or procedural function, not a diagnostic one.
The device description and intended use focus on the physical action of clearing a blockage in a medical tube, which is a direct intervention on a medical device used in patient care, not an analysis of biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
TubeClear System Clearing Stem Models are indicated for use ONLY and SOLELY in clearing occlusions/clogs in Feeding and Decompression Tubes in adult patients that have the following Tube type and size (French and length):
· 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);
· TC-0812: for Nasoenteral and Nasogastric Tubes composed of Polyviny1 Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in);
· 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);
- · 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);
- · 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); and
- · G-1014: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 36 cm (14 in).
The TubeClear System is intended to clear occlusions/clogs in Feeding and Decompression Tubes.
Product codes (comma separated list FDA assigned to the subject device)
KNT
Device Description
The TubeClear System is comprised of a reusable Control Box and a single use Clearing Stem. The Clearing Stem is connected to the Control Box. The Operator then manually inserts the Clearing Stem into the Feeding and Decompression Tube (i.e., Tube) and directs the progression of the Clearing Stem inside the Tube. The Control Box actuates the Clearing Stem Wire. The Clearing Stem Wire Tip mechanically clears the occlusion to restore Tube patency. Control Box Model 101 is used to actuate all Clearing Stem models. Sixteen (16) Clearing Stem Models are proposed to accommodate the different types, sizes, and materials of Tubes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Prescription Use
Certified and Licensed Healthcare Practitioners
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing on the material changes demonstrate substantial equivalence to the predicate devices. Performance bench testing used to support substantial equivalence was water ingress testing of the o-ring.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG" in a larger font size, with "ADMINISTRATION" written below in a smaller font size.
June 29, 2018
Actuated Medical, Inc. Michael T. Britton, M.S. Regulatory Affairs & Compliance Leader 310 Rolling Ridge Drive Bellefonte, PA 16823
Re: K172556
Trade/Device Name: TubeClear System Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT Dated: Mav 31, 2018 Received: June 1, 2018
Dear Michael T. Britton:
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.
1
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 of 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the FDA logo on the left side. On the right side, the text "Jeffrey W. Co" is present, followed by the date "2018.06.29 18" and the time zone "-04'00'". The FDA logo is in light gray, and the text is in black.
Jeffrev W. Cooper -S 18.06.29 18:35:13
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) K172556
Device Name TubeClear System
Indications for Use (Describe)
TubeClear System Clearing Stem Models are indicated for use ONLY and SOLELY in clearing occlusions/clogs in Feeding and Decompression Tubes in adult patients that have the following Tube type and size (French and length):
· 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);
· TC-0812: for Nasoenteral and Nasogastric Tubes composed of Polyviny1 Chloride (PVC) and Polyurethane that are size 8 - 12 Fr and have a length of 38 - 140 cm (15 - 55 in);
· 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);
- · 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);
- · 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); and
- · G-1014: for Gastrostomy and Jejunostomy Tubes that are of size 10 18 Fr and have a length of 36 cm (14 in).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K172556 Page 1 of 3
Image /page/3/Picture/1 description: The image shows the logo for Actuated Medical. The logo has the word "ACTUATED" in gray and "MEDICAL" in orange. Below the logo is the text "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: K172556
5.1 Applicant Information
| Date Prepared: | June 22, 2018 |
|---|---|
| Name and Address: | Actuated Medical, Inc. |
| 310 Rolling Ridge Drive | |
| Bellefonte, PA 16823 | |
| Ph: (814) 355-0003 | |
| Fx: (814) 355-1523 | |
| Contact Person: | Michael T. Britton |
| Regulatory Affairs and Compliance Leader | |
| Ph: (814) 355-0003 x118 | |
| Fx: (814) 355-1523 | |
| Email: michael.britton@actuatedmedical.com |
5.2 Device Information
| Classification: | 876.5980, product code KNT | |
|---|---|---|
| Trade Name | TubeClear System | |
| Common Name: | In Patient Tube Clearing System | |
| Classification Name: | Gastrointestinal tubes and accessories. |
5.3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are as follows:
| 510(k) Number | Trade Name | Manufacturer |
|---|---|---|
| K163092 | TubeClear System | Actuated Medical, Inc. |
| K131052 | TubeClear System | Actuated Medical, Inc. |
Image /page/3/Picture/17 description: The image is an abstract design featuring a combination of geometric and organic elements. The background consists of a checkered pattern in varying shades of orange, creating a textured effect. Overlaying this pattern is a series of wavy lines, also in orange, that meander across the image, adding a sense of movement and fluidity. The overall composition is visually engaging, with the interplay of shapes and colors creating a dynamic and modern aesthetic.
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5.4 Device Description
The TubeClear System is comprised of a reusable Control Box and a single use Clearing Stem. The Clearing Stem is connected to the Control Box. The Operator then manually inserts the Clearing Stem into the Feeding and Decompression Tube (i.e., Tube) and directs the progression of the Clearing Stem inside the Tube. The Control Box actuates the Clearing Stem Wire. The Clearing Stem Wire Tip mechanically clears the occlusion to restore Tube patency. Control Box Model 101 is used to actuate all Clearing Stem models. Sixteen (16) Clearing Stem Models are proposed to accommodate the different types, sizes, and materials of Tubes.
5.5 Intended Use
The TubeClear System is intended to clear occlusions/clogs in Feeding and Decompression Tubes.
5.6 Indications for Use of the Proposed TubeClear System
TubeClear System Clearing Stem Models are indicated for use ONLY and SOLELY in clearing occlusions/clogs in Feeding and Decompression Tubes in adult patients that have the following Tube type and size (French and length):
· 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);
· 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):
· 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);
• NE-1036: for Nasoenteral and Nasogastric Tubes that are size 10 -18 Fr and have a length of 91 cm (36 in);
• NE-1042: for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 107 cm (42 in);
• NE-1043: for Nasoenteral and Nasogastric Tubes that are size 10 -18 Fr and have a length of 109 cm (43 in);
• NE-1045: for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 114 cm (45 in);
• NE-1048: for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 122 cm (48 in);
5
· NE-1050: for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 127 cm (50 in);
· NE-1055: for Nasoenteral and Nasogastric Tubes that are size 10 - 18 Fr and have a length of 140 cm (55 in);
• G-1008: for Gastrostomy and Jejunostomy Tubes that are size 10 -18 Fr and have a length of 20 cm (8 in);
• G-1009: for Gastrostomy and Jejunostomy Tubes that are size 10 -18 Fr and have a length of 23 cm (9 in);
• G-1010: for Gastrostomy and Jejunostomy Tubes that are size 10 -18 Fr and have a length of 25 cm (10 in):
• G-1011: for Gastrostomy and Jejunostomy Tubes that are size 10 -18 Fr and have a length of 28 cm (11 in);
• G-1012: for Gastrostomy and Jejunostomy Tubes that are size 10 -18 Fr and have a length of 30 cm (12 in); and
• G-1014: for Gastrostomy and Jejunostomy Tubes that are size 10 -18 Fr and have a length of 36 cm (14 in).
5.7 Technological Characteristics
The TubeClear System referenced in this 510(k)-submission is technologically identical to the predicate devices. Changes include modified material of the Control Box O-Ring, combining the Clearing Stem models' labeling from each predicate device into a single Instructions for Use (IFU), and expanding the user population for the NE/G models from Licensed Healthcare Practitioners to Certified and Licensed Healthcare Practitioners to be consistent with the TC models.
5.8 Performance Data
Performance testing on the material changes demonstrate substantial equivalence to the predicate devices. Performance bench testing used to support substantial equivalence was water ingress testing of the o-ring.
5.9 Conclusions
The scientific data demonstrates that the Proposed Clearing Stem Models are substantially equivalent to the Predicate Clearing Stem Models.