(110 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a physical surgical tool, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for decompressing the stomach, draining fluid, and sizing the gastric pouch during surgical procedures, which are supportive functions rather than direct treatment or mitigation of a disease or condition for therapeutic purposes.
No
This device is used for surgical procedures to decompress the stomach, drain fluid, and size the gastric pouch, not to diagnose a condition.
No
The device description clearly outlines a physical, flexible gastric tube with lumens, tubing, and a balloon, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The intended use of the LAP-BAND® System Calibration Tube is for use during gastric surgical procedures to physically manipulate the stomach (decompress, drain, remove fluid, size the pouch). It is a surgical tool used directly on the patient's anatomy.
- Device Description: The description reinforces its function as a physical tool with lumens for drainage and balloon inflation, designed for use within the body during surgery.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information based on biological markers.
Therefore, the LAP-BAND® System Calibration Tube is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LAP-BAND® System Calibration Tube is indicated for use in gastric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.
Product codes
KNT
Device Description
The Lap-Band® System Calibration Tube is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
The dual lumen Calibration Tube utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate/deflate the balloon. The catheter is attached to a 32-inch suction tubing and a 6-inch tubing with a stopcock for filling the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Performance Testing - Bench
Study Type: Bench testing
Sample Size: Not specified
Key Results: All tests passed acceptance criteria.
- Burst Test of Calibration Tube Balloon: The balloon remained intact while inflated to four (4) times its recommended fill volume (25cc x 4 = 100cc).
- Sensor Tip Force to Pull: The sensor tip (distal tip) was 1.5 times greater than the acceptance criteria of the calibration balloon pull (1.5 x 13 = 19.5lbf).
- Force to Remove StopCock: The stopcock withstood a force of 1 lbf.
- Pull Force of Bushing: The bushing withstood a force of 1 lbf.
- Pull force of Fill Tube: The fill tube adhesive joint withstood a force of 1 lbf.
- Adhesive Strength Balloon Pull: The balloon withstood 13 lbf.
- End Connector Pull Force: The end connector withstood 6 lbf.
- Hybrid Calibration Tube Suction Functional Testing: Hybrid calibration tube removed all of the saline in glass beaker within 1 minute.
- Pull Force Fill Tube / Over-Mold Testing: The fill tube or over-mold joint withstood a force of 1 lb.
- Pull Force of Proximal Tubing / Over-Mold Testing: The proximal tubing or over-mold joint withstood a force of 1 lb.
Biocompatibility Testing
Study Type: Biocompatibility testing
Sample Size: Not specified
Key Results: All tests passed acceptance criteria.
- Cytotoxicity Study Using the ISO Elution Method: The CTE Score was N (non-toxic at 24, 48 and 72 hours).
- ISO Sensitization Study in the Guinea Pig: No evidence of delayed dermal contact sensitization was observed.
- ISO Vaginal Irritation Study in the Rabbit: The microscopic SC and CSO extracts were a nonirritant.
Key Metrics
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 7, 2022
ReShape Lifesciences Michelle Ravert Sr. Regulatory Specialist 1001 Calle Amanecer San Clemente, CA 92673
Re: K220455
Trade/Device Name: Lap-Band System Calibration Tube Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KNT Dated: March 8, 2022 Received: March 10, 2022
Dear Michelle Ravert:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Je Hi An. Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K220455
Device Name
LAP-BAND® System Calibration Tube
Indications for Use (Describe)
The LAP-BAND® System Calibration Tube is indicated for use in gastric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.
| 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) |
|---|---|
| ---------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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Image /page/3/Picture/1 description: The image contains the logo for ReShape Lifesciences. The logo consists of an orange partial circle on the top left, followed by the word "ReShape" in purple. Below "ReShape" is the word "Lifesciences" in gray, with a trademark symbol next to it.
510(k) Summary
I. Basic Information
| 510(k) Owner | ReShape Lifesciences
1001 Calle Amanecer
San Clemente CA 92673
Phone: (844) 937-7374
Establishment Registration No: 3013508647 |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Michelle Ravert, Regulatory Affairs Manager |
| Date summary | June 06, 2022 |
| Prepared | |
| Trade Name | Lap-Band® System Calibration Tube |
| Common Name | Introduction/Drainage Catheter |
| Classification | Class II, KNT |
| Predicate Device | ReShape Lifesciences Gastric Balloon Suction Catheter, K002838 |
II. DEVICE DESCRIPTION
The Lap-Band® System Calibration Tube is a flexible gastric tube designed to be used in gastric and bariatric surgical procedures. The catheter provides visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
The dual lumen Calibration Tube utilizes one lumen for drainage, suction and irrigation and the second lumen to inflate/deflate the balloon. The catheter is attached to a 32-inch suction tubing and a 6-inch tubing with a stopcock for filling the balloon.
III. INDICATIONS FOR USE
The Lap-Band® System Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.
IV. BASIS FOR SUBSTANTIAL EQUIVALENCE
Substantial equivalence of the Lap-Band® System Calibration Tube to the predicate device (Gastric Balloon Suction Catheter, K002838) was established through an evaluation of the indications for use, principle of operation, device design, materials of construction, and an assessment of usability, safety, and effectiveness via bench and animal studies.
The data presented in this summary demonstrates the technological similarity and equivalency of the Lap-Band® System Calibration Tube to the predicate device (Gastric Balloon Suction Catheter K002838).
4
The devices:
- · have the same intended use,
- · use the same principle of operation,
- · incorporate the same basic design,
- · use similar construction and material, and
- · are provided non-sterile and packaged using the same processes.
In summary, the Lap-Band® System Calibration Tube described in this submission is substantially equivalent to the predicate device (Gastric Balloon Suction Catheter K002838).
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A comparison of the Lap-Band® System Calibration Tube and the predicate device (Gastric Balloon Suction Catheter K002838) is provided in Table 1.
| Feature | Predicate Device
Gastric Balloon
Suction Catheter
K002838 | Subject Device
Calibration Tube | Effect on Substantial
Equivalence |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KNT | Same | None |
| Regulatory Class | Class II | Same | None |
| Regulation Number | 21 C.F.R. 876.5980 | Same | None |
| Regulation Name | Gastroenterology-
Urology | Same | None |
| Feature | Predicate Device
Gastric Balloon
Suction Catheter
K002838 | Subject Device
Calibration Tube | Effect on Substantial
Equivalence |
| Indications for Use | The Gastric Balloon
Suction Catheter is
indicated for use in
gastric and bariatric
surgical procedures to
| The LAP-BAND®
System Calibration
Tube is indicated for
use in gastric and bariatric
surgical procedures to
decompress the
stomach, drain and
remove gastric fluid
and size the gastric
pouch. | None |
| Outer Diameter | OD = 0.38" + 0.00" /
- 0.12" | Same | None |
| Working Length | 23.29" +/- 0.50" | 24.73" +/- 0.52" | No impact to
substantial
equivalence.
The additional 1.23" is
due to the presence of
the distal tip (see
Distal Tip feature
below). The addition
of the distal tip does
not affect risk. |
| Tubing | Dual lumen | Same | None |
| Distal Side Holes | 3 aspiration holes
proximal to the
balloon to ensure a
steady vacuum | Same | None |
| Feature | Predicate Device
Gastric Balloon
Suction Catheter
K002838 | Subject Device
Calibration Tube | Effect on Substantial
Equivalence |
| Distal Tip | None | Includes a tip distal to
the balloon with 12
aspiration holes. | No impact to
substantial
equivalence.
Tip aids in tracking
through the anatomy
and the holes
minimize the potential
for blockage. The
addition of the distal
tip does not affect
risk. |
| Connector for Suction | The catheter includes
an adapter for room
suction | Same | None |
| Balloon + Inflation
Valve | The balloon has an
inflation capacity $≥$
100 cc min.
The catheter is
attached to a 6-inch
tubing with a
stopcock for filling
the balloon. | Same | None |
| Tubing Material | Silicone | Same | None |
| Markings | Indication marks at
30, 35, 40, 45, and
50 centimeters. | Same | None |
| Sterility | non-sterile,
disposable, single
patient use | Same | None |
| Shelf Life | None. | 7 years | None. |
Table 1: Comparison of Subject Device and Predicate Device
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6
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VI. PERFORMANCE DATA
Comparative performance testing was conducted to demonstrate that the technological differences between the Lap-Band® System Calibration Tube and the predicate device (Gastric Balloon Suction Catheter, K002838) do not raise concerns of substantial equivalence.
Performance Testing - Bench
Refer to Table 2 below for a summary of the performance testing performed on the Lap-Band® System Calibration Tube.
| Test Performed | Acceptance Criteria | Results |
|---|---|---|
| Burst Test of | ||
| Calibration Tube | ||
| Balloon | The balloon must remain intact while inflated to four (4) times its recommend fill volume (25cc x 4 = 100cc). | Pass |
| Sensor Tip Force to | ||
| Pull | The sensor tip (distal tip) must be 1.5 times greater than the acceptance criteria of the calibration balloon pull (1.5 x 13 = 19.5lbf). | Pass |
| Force to Remove | ||
| StopCock | The stopcock must withstand a force of 1 lbf. | Pass |
| Pull Force of Bushing | The bushing must withstand a force of 1 lbf. | Pass |
| Pull force of Fill Tube | The fill tube adhesive joint must withstand a force of 1 lbf. | Pass |
| Adhesive Strength | ||
| Balloon Pull | The balloon must withstand 13 lbf. | Pass |
| End Connector Pull | ||
| Force | The end connector must withstand 6 lbf. | Pass |
| Hybrid Calibration | ||
| Tube Suction | ||
| Functional Testing | Hybrid calibration tube must remove all of the saline in glass beaker within 1 minute. | Pass |
| Pull Force Fill Tube / | ||
| Over-Mold Testing | The fill tube or over-mold joint must withstand a force of 1 lb. This component's only function is to provide a path for inflation of the balloon. | Pass |
| Pull Force of Proximal | ||
| Tubing / Over-Mold | ||
| Testing | The proximal tubing or over-mold joint must withstand a force of 1 lb. | Pass |
Table 2: Summary of Non-Clinical Bench Testing for the Subject Device
8
Biocompatibility Testing
Refer to Table 3 below for a summary of the biocompatibility testing performed on Lap-Band® System Calibration Tube.
| Biocompatibility Test | Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity Study | ||
| Using the ISO Elution | ||
| Method | Observations for test and negative control | |
| at 24, 48 and 72 hours. Presence or | ||
| absence of a confluent monolayer, | ||
| vacuolization, cellular swelling and | ||
| crenation and the percentage of cellular | ||
| lysis are recorded. Scoring was nontoxic, | ||
| intermediate, or toxic. | The CTE Score was N | |
| (non-toxic at 24, 48 and | ||
| 72 hours). | ||
| ISO Sensitization | ||
| Study in the Guinea | ||
| Pig | The response, pattern, character, and | |
| duration of any test animal reactions are | ||
| compared to any reactions in the controls. | ||
| Any dermal inflammatory response at the | ||
| test sites greater than that seen in any | ||
| control condition is considered evidence | ||
| of a potential allergic response. | No evidence of delayed | |
| dermal contact | ||
| sensitization was | ||
| observed. | ||
| ISO Vaginal | ||
| Irritation Study in the | ||
| Rabbit | Each animal was observed daily for | |
| general health and external signs of | ||
| irritation around the opening of the | ||
| vaginal vestibule. After euthanization, | ||
| tissue sections were evaluated. | ||
| Macroscopic reactions were compared | ||
| between test and control animals. | ||
| Microscopic evaluation scores for all SC | ||
| test animals were added together and | ||
| divided by the number of test animals to | ||
| obtain the SC average. The CSO averages | ||
| were similarly calculated. The Irritation | ||
| Index was scored from zero to 16, with | ||
| zero as nonirritant and 16 severe irritant. | The microscopic SC | |
| and CSO extracts were | ||
| a nonirritant. |
| Table 3: Biocompatibility Testing Summary - Subject Device | |
|---|---|
9
VII. CONCLUSION
ReShape Lifesciences concludes, through a review of the non-clinical assessments, the comparison of the device classifications for use, operating principle, technological characteristics, and biocompatibility that the subject device, the Lap-Band® System Calibration Tube, is substantially equivalent to the predicate device, the Gastric Balloon Suction Catheter (K002838). Any differences between the subject device and the predicate device do not raise different questions of safety and effectiveness.