(22 days)
No
The device description and performance testing sections focus on mechanical function and physical properties, with no mention of AI/ML technologies or data processing.
No
The device is described as a surgical instrument used to grasp, clamp, and manipulate soft tissues during laparoscopic procedures. It is used to facilitate surgical operations, not to treat a disease or condition itself.
No
The device description indicates its use is for grasping, clamping, and manipulating soft tissues during laparoscopic surgical procedures, not for diagnosing medical conditions.
No
The device description clearly describes a physical, hand-held surgical instrument with mechanical components (handle, shaft, end effector, jaws, trigger, release button) used for grasping and manipulating tissue. There is no mention of software as a component or function of the device.
Based on the provided text, 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 tool used directly on the patient's body.
- Device Description: The description details a surgical instrument with a handle, shaft, and end effector for physically interacting with tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely mechanical manipulation during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such analysis.
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. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.
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 stomach. 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 clamp is comp 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. The current Standard Clamp, Disposable has a jaw length of 25 cm. This Special 510(k) is being filed to add a new shorter jaw length (22 cm) to accommodate patients with smaller abdomens.
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 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.
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
surgeon / hospital
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)
Standard Clamp, Disposable performance bench testing was provided in K170379. Testing for the Standard Clamp, Disposable 22 cm is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Standard Clamp, Disposable 25 cm previously provided in K 170379. The data demonstrates that the Standard Clamp, Disposable 22 cm meets the same specifications for clamping and slip force as the Standard Clamp, Disposable 25 cm. The packaging change has been validated and data is provided in Section 014 - Sterilization and Shelf Life.
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
§ 876.1500 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.
0
Image /page/0/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a stylized red letter "S" enclosed in a rounded square on the left, followed by the words "STANDARD BARIATRICS" in black, sans-serif font on the right. The trademark symbol is located to the right of the word "BARIATRICS".
510(K) Summary
I. SUBMITTER
Standard Bariatrics 4362 Glendale Milford Road Cincinnati, OH 45242 USA
Phone: 513-304-7971 Email: alison(@standardbariatrics.com
Contact Person: Alison Sathe Date Prepared: March 15, 2019
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, Disposable K181608
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 stomach. 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 clamp is comp 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. The current Standard Clamp, Disposable has a jaw length of 25 cm. This Special 510(k) is being filed to add a new shorter jaw length (22 cm) to accommodate patients with smaller abdomens.
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 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.
V. INDICATIONS FOR USE
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Image /page/1/Picture/1 description: The image is a logo for Standard Bariatrics. The logo features a red square with a stylized white "S" inside of it. To the right of the square is the text "STANDARD BARIATRICS" in black, bold letters. The letters are all capitalized, and there is a trademark symbol after the word "BARIATRICS".
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE
The Standard Clamp, Disposable has the same technological characteristics as the predicate device with the exception of jaw length.
| Table 1: Technological Characteristics | |
|---|---|
| Product | Predicate Standard Clamp, Disposable
(product code SCD25)
(K181608) | Standard Clamp, Disposable
(product code SCD22)
(Subject) |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | The Standard Clamp, Disposable is
indicated for use in laparoscopic
procedures to grasp, clamp, and
manipulate soft tissues. The Clamp is
indicated for use in bariatric procedures
such as sleeve gastrectomy as a guide, to
clamp and manipulate flat tissue and
organs, such as the stomach. | Same |
| Disposable/Reusable | Disposable | Same |
| Materials | End Effector: aluminum
Shaft: stainless steel
Handle: polycarbonate | Same |
| Overall Length | 26.3 inches (66.8 cm) | 25.1 inches (63.8 cm) |
| End Effector Length | 10.6 inches (27 cm) | 9.4 inches (24 cm) |
| End Effector Clamping Length | 9.8 inches (25 cm) | 8.9 inches (22 cm) |
| End Effector Width | 0.47 inches (12 mm) | Same |
| Shaft Width | 0.39 inches (10 mm) | Same |
| Weight | 0.5 lbs. | 0.5 lbs. |
| Articulation | None | Same |
| End effector design | Aluminum jaws with non-piercing
ridges to grasp tissue | Same |
| End effector closure | Distal to proximal closure | Same |
| Handle | Pistol grip | Same |
2
| Sterilization Method | Gamma Sterilization | Same |
|---|---|---|
| Anatomical Site Used | Various soft tissues accessible during | |
| laparoscopic procedures | Same | |
| Types of procedures | Laparoscopic procedures | Same |
| Energy Delivered? | No | Same |
| Compatible with 12 mm trocar? | Yes | Same |
| Biocompatibility | Biocompatible for blood/bone/tissue | |
| contact for limited duration | Same | |
| Packaging | Tyvek pouch in a cardboard box | Tyvek covered tray in cardboard box |
VII. PERFORMANCE DATA
Standard Clamp, Disposable performance bench testing was provided in K170379. Testing for the Standard Clamp, Disposable 22 cm is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Standard Clamp, Disposable 25 cm previously provided in K 170379. The data demonstrates that the Standard Clamp, Disposable 22 cm meets the same specifications for clamping and slip force as the Standard Clamp, Disposable 25 cm. The packaging change has been validated and data is provided in Section 014 - Sterilization and Shelf Life.
VIII. CONCLUSIONS
The Standard Clamp, Disposable has the same intended use and principles of operation as its predicate device. The only difference in technological characteristics is the jaw being offered in a shorter length in order to accommodate varying anatomy. The Standard Clamp, Disposable 22 cm meets the same specifications as the previously cleared Standard Clamp, Disposable 25 cm. There are no new issues of safety or effectiveness. Standard Clamp, Disposable is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows 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 acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name written out as "U.S. Food & Drug Administration".
Standard Bariatrics Alison Sathe, Regulatory 4362 Glendale Milford Rd. Cincinnati. Ohio 45242
April 18, 2019
Re: K190788
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: March 21, 2019 Received: March 27, 2019
Dear Alison 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. 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 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
4
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-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,
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
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