(162 days)
Not Found
No
The device description and performance studies focus on mechanical function and equivalence to a predicate device, with no mention of AI/ML capabilities or data processing.
No
The device is a surgical instrument used to grasp, clamp, and manipulate tissues during laparoscopic procedures. It does not provide any therapeutic effect.
No
The device is described as a surgical instrument used to grasp, clamp, and manipulate soft tissues during laparoscopic procedures. There is no mention of it being used for diagnosis or generating diagnostic information.
No
The device description clearly outlines a physical, hand-held surgical instrument with mechanical components (handle, shaft, end effector, jaws, trigger, release button). It is described as disposable, non-energized, and provided sterile, all characteristics of a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "grasp, clamp, and manipulate soft tissues" during laparoscopic procedures. This is a surgical function performed directly on the patient's body.
- Device Description: The description details a surgical instrument with a handle, shaft, and end effector designed for physical manipulation of tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
This device is clearly a surgical instrument used for therapeutic and manipulative purposes during a procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Various soft tissues accessible during laparoscopic procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. The environment of use is in a hospital during laparoscopic surgical procedures.
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)
Bench testing was provided and demonstrated substantial equivalence to the predicate device. Clinical testing was not provided.
Table 2: Bench Testing Summary
- Reliability Testing: Standard Clamp, Disposable devices were tested in simulated use conditions to demonstrate reliability of the device to perform 6 use cycles (i.e. opening and closure cycles) per the device specifications. Testing was completed per the protocol without deviations. All samples met the requirements for trocar insertion, visual inspection and functional performance for each cycle. Standard Clamp, Disposable devices were cycled in simulated use cycles with zero failures. The Standard Clamp, Disposable was tested to 95% reliability at 90% confidence, demonstrating the ability to perform for its intended use, similar to the predicate device.
- Tissue Compression: Standard Clamp, Disposable devices were tested using excised porcine stomach to compare the clamping forces of the Standard Clamp, Disposable to the predicate device, reusable Standard Clamp. Testing was completed per the protocol without deviations. Thirty (30) test runs demonstrated the Standard Clamp, Disposable compressed tissue with forces less than or equal to that of the Standard Clamp, Reusable. Testing demonstrates that the clamping forces of the Standard Clamp, Disposable is less than or equal to that of the reusable Standard Clamp.
- Tissue Slippage: Standard Clamp, Disposable devices were tested using excised porcine stomach to verify that the tissue will not slip from the jaws when a working load (i.e. a maximum load typically applied in surgical procedures) is applied to the tissue. Testing was completed per the protocol without deviations. Thirty (30) test runs demonstrated that tissue did not slip from the Standard Clamp, Disposable jaws when a working load was applied to the tissue. Testing demonstrates that tissue will not slip from the jaws of the Standard Clamp, Disposable 95% probability with 90% confidence. This demonstrates functionality substantially equivalent to the predicate device, reusable Standard Clamp.
- Closure Strength: Standard Clamp, Disposable devices were tested to ensure the closure mechanism has a safety margin greater than or equivalent to 1.5. A safety margin of 1.5 ensures that the worst-case stress on the closure system will not exceed the strength of the device closure system (i.e. the device jaws will remain closed when placed in the closed position). Testing was completed per the protocol without deviations. Ten (10) test runs demonstrated that the closure mechanism demonstrated a safety margin of 11.6, exceeding the required safety margin. Testing demonstrates that the Standard Clamp, Disposable closure system is functional for device use. Testing demonstrates that the Standard Clamp, Disposable closure mechanism is substantially equivalent to that of the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
reliability at 95% with 90% confidence, safety margin of 11.6
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping each other. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the top of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
Standard Bariatrics Ms. Alison Sathe VP of Regulatory Affairs 4362 Glendale Milford Rd. Cincinnati, Ohio 45242
Re: K170379
Trade/Device Name: Disposable Standard Clamp Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 1, 2017 Received: February 7, 2017
Dear Ms. Sathe:
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 Actinclude 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,
Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, sans-serif font. The text is arranged in two lines, with "Jennifer R." on the first line and "Stevenson -S3" on the second line. The background is a light blue color, and the text is dark.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170379
Device Name Standard Clamp, Disposable
Indications for Use (Describe)
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
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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Image /page/3/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized white "S" inside, followed by the words "STANDARD" and "BARIATRICS" in black, bold sans-serif font. The trademark symbol is located to the right of the word "BARIATRICS".
510(K) Summary
SUBMITTER l.
Standard Bariatrics 4362 Glendale Milford Road Cincinnati, OH 45242 USA
Phone: 513-30407971 Email: alison@standardbariatrics.com
Contact Person: Alison Sathe Date Prepared: Feb. 1, 2017
II. DEVICE
Name of Device: Standard Clamp, Disposable Common or Usual Name: Laparoscopic Surgical Instrument Classification Name: Endoscope and Accessories (21 CFR 876.1500) Regulatory Class: II Product Code: GCJ
III. PREDICATE DEVICE
Standard Bariatrics Standard Clamp, K161720 This predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The end effector of the clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures.
V. INDICATIONS FOR USE
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
VI. INTENDED USE
The Standard Clamp, Disposable is intended to be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. The Standard Clamp, Disposable is intended to
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Image /page/4/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized "S" inside, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The logo is clean and modern, with a focus on the company name.
be inserted into the peritoneal cavity through a 12mm trocar and used in up to six cycles of opening and closure to grasp, clamp and manipulate long, 1.2 to 4.5mm thick, planes of soft tissues such as the stomach. The Standard Clamp, Disposable is not intended for direct contact with the cardiovascular system, lymphatic system or cerebrospinal fluid. The Standard Clamp, Disposable can be used while a surgeon uses devices such as a stapler adjacent to tissue that is clamped with the Standard Clamp, Disposable, e.g., to help guide endoscopic staplers during resection of tissue such as in sleeve gastrectomy.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VII.
| Product | Standard Clamp, Disposable
(proposed) | Standard Clamp, Reusable
(161720) |
|----------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Disposable/Reusable | Disposable | Reusable |
| Materials | End Effector: aluminum
Shaft: stainless steel
Handle: polycarbonate | End Effector: stainless steel
Shaft: stainless steel
Handle: stainless steel |
| Overall Length | 26.3 inches (66.8 cm) | 25.4 inches (64.5 cm) |
| End Effector Length | 10.6 inches (27 cm) | 10.6 inches (27 cm) |
| End Effector Width | 0.47 inches (12 mm) | 0.47 inches (12 mm) |
| Shaft Width | 0.39 inches (10 mm) | 0.39 inches (10 mm) |
| Weight | 0.5 lbs. | 1.7 lbs. |
| Articulation | none | up to 55° from midline |
| End effector design | Aluminum jaws with non-piercing ridges
to grasp tissue | Stainless steel jaws with non-piercing ridges
to grasp tissue |
| End effector closure | Distal to proximal closure | Parallel closure |
| Handle | Pistol grip | Inline grip |
| Sterilization Method | Gamma Sterilization | Steam Sterilization |
| Anatomical Site Used | Various soft tissues accessible during
laparoscopic procedures | Various soft tissues accessible during
laparoscopic procedures |
| Types of procedures | Laparoscopic procedures | Laparoscopic procedures |
| Energy Delivered? | No | No |
| Compatible with 12
mm trocar? | Yes | Yes |
| Biocompatibility | Biocompatible for blood/bone/tissue
contact for limited duration | Biocompatible for blood/bone/tissue
contact for limited duration |
| Packaging | Tyvek pouch in cardboard box | Plastic pouch in cardboard box |
Table 1: Technological Characteristics
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Image /page/5/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a red square with a stylized white "S" inside, followed by the words "STANDARD BARIATRICS" in black, sans-serif font. The "TM" symbol is located to the right of the word "BARIATRICS".
VIII. PERFORMANCE DA
Standard Clamp, Disposable performance bench testing was provided and demonstrated substantial equivalence to the predicate device. Clinical testing was not provided. Bench testing provided is described in Table 2.
Table 2: Bench Testing Summary
| Testing | Purpose of Testing | Results | How Results Support |
|---|---|---|---|
| Reliability | |||
| Testing | Standard Clamp, Disposable | ||
| devices were tested in simulated | |||
| use conditions to demonstrate | |||
| reliability of the device to perform | |||
| 6 use cycles (i.e. opening and | |||
| closure cycles) per the device | |||
| specifications. | Testing was completed per the | ||
| protocol without deviations. All | |||
| samples met the requirements | |||
| for trocar insertion, visual | |||
| inspection and functional | |||
| performance for each cycle. | |||
| Standard Clamp, Disposable | |||
| devices were cycled in simulated | |||
| use cycles with zero failures. | Substantial Equivalence | ||
| The Standard Clamp, | |||
| Disposable was tested to | |||
| 95% reliability at 90% | |||
| confidence, demonstrating | |||
| the ability to perform for its | |||
| intended use, similar to the | |||
| predicate device. | |||
| Tissue | |||
| Compression | Standard Clamp, Disposable | ||
| devices were tested using excised | |||
| porcine stomach to compare the | |||
| clamping forces of the Standard | |||
| Clamp, Disposable to the predicate | |||
| device, reusable Standard Clamp. | Testing was completed per the | ||
| protocol without deviations. | |||
| Thirty (30) test runs | |||
| demonstrated the Standard | |||
| Clamp, Disposable compressed | |||
| tissue with forces less than or | |||
| equal to that of the Standard | |||
| Clamp, Reusable. | Testing demonstrates that | ||
| the clamping forces of the | |||
| Standard Clamp, Disposable | |||
| is less than or equal to that | |||
| of the reusable Standard | |||
| Clamp. | |||
| Tissue | |||
| Slippage | Standard Clamp, Disposable | ||
| devices were tested using excised | |||
| porcine stomach to verify that the | |||
| tissue will not slip from the jaws | |||
| when a working load (i.e. a | |||
| maximum load typically applied in | |||
| surgical procedures) is applied to | |||
| the tissue. | Testing was completed per the | ||
| protocol without deviations. | |||
| Thirty (30) test runs | |||
| demonstrated that tissue did | |||
| not slip from the Standard | |||
| Clamp, Disposable jaws when a | |||
| working load was applied to the | |||
| tissue. | Testing demonstrates that | ||
| tissue will not slip from the | |||
| jaws of the Standard Clamp, | |||
| Disposable 95% probability | |||
| with 90% confidence. This | |||
| demonstrates functionality | |||
| substantially equivalent to | |||
| the predicate device, | |||
| reusable Standard Clamp. | |||
| Closure | |||
| Strength | Standard Clamp, Disposable | ||
| devices were tested to ensure the | |||
| closure mechanism has a safety | |||
| margin greater than or equivalent | |||
| to 1.5. A safety margin of 1.5 | |||
| ensures that the worst-case stress | |||
| on the closure system will not | |||
| exceed the strength of the device | |||
| closure system (i.e. the device | |||
| jaws will remain closed when | |||
| placed in the closed position). | Testing was completed per the | ||
| protocol without deviations. Ten | |||
| (10)) test runs demonstrated | |||
| that the closure mechanism | |||
| demonstrated a safety margin of | |||
| 11.6, exceeding the required | |||
| safety margin | Testing demonstrates that | ||
| the Standard Clamp, | |||
| Disposable closure system is | |||
| functional for device use. | |||
| Testing demonstrates that | |||
| the Standard Clamp, | |||
| Disposable closure | |||
| mechanism is substantially | |||
| equivalent to that of the | |||
| predicate. |
CONCLUSIONS
The Standard Clamp, Disposable has the same indications, technological characteristics, principles of operation as its predicate device. There are no new issues of safety or effectiveness. Standard Clamp, Disposable is substantially equivalent to the predicate device.