(164 days)
Not Found
Not Found
No
The device description and performance studies indicate a purely mechanical, non-energized surgical instrument with no mention of AI/ML terms or data-driven components.
No
The device is described as a surgical instrument used to grasp, clamp, and manipulate soft tissues during open procedures. While it interacts with tissues, its function is primarily manipulative and supportive during surgery, rather than directly treating or mitigating a disease or condition. The performance studies focus on its mechanical ability and tissue effect rather than therapeutic outcomes.
No
The device is described as a surgical instrument used to grasp, clamp, and manipulate soft tissues during open procedures. Its function is to physically interact with tissue, not to diagnose conditions or process diagnostic information. The performance studies evaluate its mechanical interaction with tissue, not its ability to detect or identify medical conditions.
No
The device description explicitly states it is a reusable, non-energized, stainless steel surgical instrument with physical components (handle, shaft, end effector). It is a hardware device, not software.
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" in open surgical procedures. This is a direct interaction with the patient's body during a procedure, not an analysis of samples taken from the body.
- Device Description: The device is a "reusable, non-energized, stainless steel surgical instrument." This describes a tool used in surgery, not a device for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting markers, or providing diagnostic information based on laboratory tests.
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's function is purely mechanical manipulation of tissue during surgery.
N/A
Intended Use / Indications for Use
The Standard Clamp is indicated for use in open procedures to grasp, clamp, and manipulate soft tissues.
Product codes (comma separated list FDA assigned to the subject device)
GDJ
Device Description
The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Various soft tissues
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical evaluation of the Standard Clamp was performed to ensure the device may be used as designed. The device ability to clamp the stomach was evaluated in vivo. Tissue effects from the Standard Clamp were compared to other surgical devices including surgical staplers, soft tissue clamps, and graspers in a histological assessment. The Standard Clamp demonstrated little or no tissue effect after being clamped on stomach for an extended period of time as observed under histology. The Standard Clamp exhibited less tissue damage compared to graspers and surgical staplers with the exception of the Doyen clamp which also demonstrated no damage to tissue. Testing demonstrates acceptable performance of the Standard Clamp, its ability to clamp the stomach, and non-traumatic tissue effect.
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.
Doyen Atraumatic Bowel Clamp
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
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is facing right, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 2, 2016
Standard Bariatrics Ms. Alison Sathe Director Of Regulatory 4362 Glendale Milford Rd. Cincinnati, Ohio 45242
Re: K153358
Trade/Device Name: Standard Clamp Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class I Product Code: GDJ Dated: March 27, 2016 Received: April 4, 2016
Dear Ms. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 yours,
Jennifer R. Stevenson -A
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) K153358
Device Name Standard Clamp
Indications for Use (Describe)
The Standard Clamp is indicated for use in open 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)
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 is a logo for Standard Bariatrics. The logo features a stylized red "S" on the left, followed by the words "STANDARD" and "BARIATRICS" in black, stacked on top of each other. The "S" is made up of three horizontal lines, and the word "BARIATRICS" has a trademark symbol next to it.
510(K) Summary
This 510(K) Summary of safety and effectiveness for the Standard Clamp is submitted in accordance with 21 CFR 807.92.
| Submitter Information | |
|---|---|
| Applicant Name | Standard Bariatrics |
| Address | Standard Bariatrics |
| 4362 Glendale Milford Road | |
| Cincinnati, OH 45242 USA | |
| Contact Person | Alison Sathe |
| Regulatory, Standard Bariatrics | |
| 513-304-7971 | |
| alison@standardbariatrics.com | |
| Preparation Date | December 7, 2015 |
| Device Information | |
| Device Trade Name | Standard Clamp |
| Common Name | Manual Surgical Instrument |
| Classification Name | Manual surgical instrument for general use |
| Classification Panel | 79 General and Plastic Surgery |
| Regulation | Class I per 32 CFR 878.4800, product code GDJ |
| Legally Marketed Predicate | |
| Device(s) | Doyen Atraumatic Bowel Clamp |
| Product Code | SCR25 |
| Reason for 510(k) | New Device |
| Device Description | The Standard Clamp is a reusable, non-energized, stainless steel surgical instrument. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is an inline grip with two knobs which are manually rotated in order to manipulate the end effector. The end effector of the clamp is comprised of an upper and lower jaw that close parallel in order to grasp tissue. |
| Intended Use | The Standard Clamp is a hand held device used to clamp long planes of soft tissues. The device allows the surgeon to clamp and manipulate flat tissue and organs, such as the stomach. The clamp can also be used by the surgeon to help guide staplers during transection of tissue. |
| Indications for Use: | The Standard Clamp is indicated for use in open procedures to grasp, clamp and manipulate soft tissues |
Technological Characteristics: The Standard Clamp is a non-energized, manually articulated, surgical clamp. The device is comprised of stainless steel and is validated for sterilization by steam autoclave. Two knobs on the device handle allow the user to adjust the angle of the end effector with respect to the shaft and open/close the jaws. Technical specifications are as follows:
4
Image /page/4/Picture/0 description: The image shows the logo for Standard Bariatrics. The logo consists of a red, stylized letter "S" enclosed in a rounded square on the left. To the right of the symbol, the words "STANDARD" and "BARIATRICS" are written in bold, black capital letters, stacked vertically. A small trademark symbol appears next to the word "BARIATRICS".
| Product | Standard Clamp | Doyen Atraumatic Bowel Clamp |
|---|---|---|
| Type of Device | Reusable | Reusable |
| Materials (end | ||
| effector) | Stainless Steel | Stainless Steel |
| Length | 25.4 inches (64.5 cm) | 9 inches |
| Weight | 1.7 lbs. | unknown |
| Articulation | ||
| Mechanism | Rotating knob on handle | none |
| Articulation | up to 55° from midline | Available in curved or straight configuration |
| End effector design | Stainless steel jaws with non-piercing ridges to | Stainless steel jaws with non-piercing ridges |
| grasp tissue | to grasp tissue | |
| End effector closure | Parallel closure | Scissor-type closure |
| Handle | In-line grip | In-line grip |
| Sterilization Method | Steam Sterilization | Steam Sterilization |
| Flush Port | Yes | No |
| Anatomical Site Used | Various soft tissues | Various soft tissues |
| Energy Delivered | No | No |
| Biocompatibility | Biocompatible for blood/bone/tissue contact | Biocompatible for blood/bone/tissue contact |
| for limited duration | for limited duration |
Performance Data:
Pre-clinical evaluation of the Standard Clamp was performed to ensure the device may be used as designed. The device ability to clamp the stomach was evaluated in vivo. Tissue effects from the Standard Clamp were compared to other surgical devices including surgical staplers, soft tissue clamps, and graspers in a histological assessment. The Standard Clamp demonstrated little or no tissue effect after being clamped on stomach for an extended period of time as observed under histology. The Standard Clamp exhibited less tissue damage compared to graspers and surgical staplers with the exception of the Doyen clamp which also demonstrated no damage to tissue. Testing demonstrates acceptable performance of the Standard Clamp, its ability to clamp the stomach, and non-traumatic tissue effect.
Substantial Equivalence:
The Standard Clamp has the same indications, technological characteristics, principles of operation as its predicate devices. There are no new issues of safety or effectiveness. Thus, the Standard Clamp is substantially equivalent to the predicate devices.